IMOVA: Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging
Study Details
Study Description
Brief Summary
This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent. It is a single center evaluation of the study treatment.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Functional imaging A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) |
Device: Functional Imaging previous the second course
Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1
Device: Functional Imaging previous the surgery
Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval
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Outcome Measures
Primary Outcome Measures
- Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location [Pre-therapeutic]
Individual intra-class correlation coefficients by location (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
- Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location [Pre-therapeutic]
Average intra-class correlation coefficients(Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
- Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location [Pre-therapeutic]
Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
- Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location [Pre-therapeutic]
Average intra-class correlation coefficients (Absolute agreement) arepresented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
- Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location [Pretherapeutic]
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
- Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location [Pretherapeutic]
Average intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
- Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location [After one cycle of chemotherapy, 3 weeks]
Individual Intra-class Correlation (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted twice by radiologist and nuclear medicine specialist.
- Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location [After one cycle of chemotherapy, 3 weeks]
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET) . The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
- Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location [After one cycle of chemoterapy, 3 weeks]
Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
- Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location [After one cycle of chemotherapy, 3 weeks]
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
- Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location [After one cycle of chemotherapy, 3 weeks]
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
- Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location [After one cycle of chemotherapy, 3 weeks]
Average intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
- Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location [After four cycles of chemotherapy, 12 weeks]
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
- Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location [After four cycles of chemotherapy, 12 weeks]
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
- Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location [After four cycles of chemoterapy, 12 weeks]
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
- Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by Location [After four cycles of chemotherapy, 12 weeks]
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
- Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location [After four cycles of chemotherapy, 12 weeks]
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
- Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location [After four cycles of chemotherapy, 12 weeks]
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter of ADC functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
- Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location [Pre-therapeutic]
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter ADC of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
- Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location [Pre-therapeutic]
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
- Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location [Pre-therapeutic]
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
- Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location [Pre-therapeutic]
Average Intra-class Correlation Coefficients by Location (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
- Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location [Pretherapeutic]
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
- Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location [Pretherapeutic]
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI) . The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
- Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location [After one cycle of chemoterapy, 3 weeks]
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUV max of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
- Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location [After once cycle of chemoterapy, 3 weeks]
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
- Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location [After one cycle of chemoterapy, 3 weeks]
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
- Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location [After once cycle of chemotherapy, 3 weeks]
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
- Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location [After one cycle of chemotherapy, 3 weeks]
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
- Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location [After one cycle of chemotherapy, 3 weeks]
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
- Individual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location [After four cycles of chemoterapy, 12 weeks]
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
- Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location [After four cycles of chemoterapy, 12 weeks]
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
- Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location [After four cycle of chemoterapy, 12 weeks]
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
- Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location [After four cycles of chemotherapy, 12 weeks]
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
- Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location [After four cycles of chemotherapy, 12 weeks]
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
- Intra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location [After four cycles of chemotherapy, 12 weeks]
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
Secondary Outcome Measures
- Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG) [After one cycle of chemotherapy, 3 weeks]
In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 cycle of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.
- Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG) [After four cycles of chemotherapy, 12 weeks]
In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.
- Spearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125 [After one and four cycle(s) of chemotherapy (after 3 and 12 weeks)]
In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value.
- Complete Surgery Resection [Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery]
- Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1 [After one cycle of chemotherapy, 3 weeks]
In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
- Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1 [After four cycles of chemotherapy, 12 weeks]
In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. RRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
- Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1 [After four cycles of chemotherapy, 12 weeks]
In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
- Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1 [After one cycle of chemotherapy, 3 weeks]
In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
- Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1 [After one cycle of chemotherapy, 3 weeks]
In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
- Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1 [After four cycles of chemotherapy, 12 weeks]
In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
- Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1 [After one cycle of chemotherapy, 3 weeks]
In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
- Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1 [After four cycles of chemotherapy, 12 weeks]
In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
- Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1 [After one cycle of chemotherapy, 3 weeks]
In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
- Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1 [After four cycles of chemotherapy, 12 weeks]
In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
- Descriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1 [After one cycle of chemotherapy, 3 weeks]
In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
- Descriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1 [After four cycles of chemotherapy, 12 weeks]
In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0).
- Peritoneal Extent Assessed by Fagotti Score Using MRI Data [Pre-therapeutic]
The Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of subscale values corresponds to Fagotti score.
- Peritoneal Extent Assessed by Fagotti Score Using MRI Data [Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery]
TThe Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of subscales corresponds to Fagotti score.
- Overall Survival [10 months]
- Progression-free Survival as Per RECIST v1.1 [9, 13, 14 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Epithelial ovarian carcinoma, fallopian tube, or primary peritoneal carcinoma FIGO IIIC-IV histologically confirmed by biopsy and documented stage and untreated
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Pre-treatment abdominopelvic PET-CT and MRI within 4 weeks before neoadjuvant chemotherapy.
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During laparoscopy performed by an experienced surgeon in the treatment of ovarian cancer, patient considered ineligible for tumor cell kill at the outset.
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A life expectancy of greater than three months
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An eligible patient for Paclitaxel and Carboplatine based chemotherapy.
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Membership of a social security scheme
-
Patient information and signed, dated written informed consent
Exclusion Criteria:
-
Pre-treated using chemotherapy, radiology, or surgery for an ovarian cancer.
-
Contraindication to MRI with the injection of contrast product, i.e, the first three months pregnancy, claustrophobia, major allergic antecedents, pacemaker, some surgery clips, some heart valves, cava filter, implanter pumps, cochlear implants, metallic extraneous malter.
-
Uncontrolled diabetes
-
Pregnancy and nursing
-
Other uncontrolled medical conditions as thyroid pathology, neuropsychiatric disease, infection, coronary insufficiency or grade 3 - 4 heart disease established by association "New York Heart"
-
Patient deprived of liberty and legally protect adult, or not in position to give consent.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Institut Bergonié | Bordeaux | Gironde | France | 33076 |
Sponsors and Collaborators
- Institut Bergonié
- Roche Pharma AG
- Ligue contre le cancer, France
Investigators
- Study Chair: Anne-Laure CAZEAU, MD, Institut Bergonié
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Registre des essais cliniques de l'Institut National du Cancer
- Site internet du promoteur, l'Institut Bergonié
Publications
None provided.- IB 2013-03
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | The first steering committee (which met on 30th June, 2015) decided that one patient was not assessable for primary endpoint and had to be replaced. This patient deceased after the first line chemotherapy. |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Period Title: Overall Study | |
STARTED | 11 |
COMPLETED | 10 |
NOT COMPLETED | 1 |
Baseline Characteristics
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Overall Participants | 11 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
67.0
|
Sex: Female, Male (Count of Participants) | |
Female |
11
100%
|
Male |
0
0%
|
Race and Ethnicity Not Collected (Count of Participants) | |
Proven epithelial carcinoma of gynaecological origin (Count of Participants) | |
Yes |
11
100%
|
No |
0
0%
|
Location of the tumour (Count of Participants) | |
Ovaries |
9
81.8%
|
Trunk |
1
9.1%
|
Primitive peritoneal |
1
9.1%
|
Histological type (Count of Participants) | |
Serous |
11
100%
|
Other type |
0
0%
|
Stage of the tumour (Count of Participants) | |
III-c |
5
45.5%
|
IV |
6
54.5%
|
Total Fagotti Score (Count of Participants) | |
4 |
2
18.2%
|
8 |
4
36.4%
|
10 |
3
27.3%
|
12 |
1
9.1%
|
Not available |
1
9.1%
|
Performance status ECOG (Count of Participants) | |
Not available |
1
9.1%
|
0 |
4
36.4%
|
1 |
6
54.5%
|
Weight (Kg) [Median (Full Range) ] | |
Median (Full Range) [Kg] |
59.0
|
Height (cm) [Median (Full Range) ] | |
Median (Full Range) [cm] |
164.0
|
Number of measurable initial lesions (Count of Participants) | |
1 |
2
18.2%
|
2 |
2
18.2%
|
3 |
1
9.1%
|
4 |
3
27.3%
|
5 |
3
27.3%
|
Number of non-target lesions (Count of Participants) | |
2 |
3
27.3%
|
3 |
5
45.5%
|
4 |
1
9.1%
|
5 |
2
18.2%
|
Sum of the diameters (diameters) [Median (Full Range) ] | |
Median (Full Range) [diameters] |
176.0
|
Outcome Measures
Title | Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual intra-class correlation coefficients by location (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
Time Frame | Pre-therapeutic |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable population |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.992
|
Sus-mesocolic |
0.997
|
Sub-mesocolic |
0.983
|
Pelvis |
0.997
|
Viscera |
0.951
|
ADP |
0.960
|
Title | Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location |
---|---|
Description | Average intra-class correlation coefficients(Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
Time Frame | Pre-therapeutic |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable population |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.996
|
Sus-mesocolic |
0.999
|
Sub-mesocolic |
0.992
|
Pelvis |
0.998
|
Viscera |
0.975
|
ADP |
0.980
|
Title | Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
Time Frame | Pre-therapeutic |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable population |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.482
|
Sus-mesocolic |
0.450
|
Sub-mesocolic |
0.137
|
Pelvis |
0.747
|
Viscera |
0.023
|
ADP |
0.881
|
Title | Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location |
---|---|
Description | Average intra-class correlation coefficients (Absolute agreement) arepresented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
Time Frame | Pre-therapeutic |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable population |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.650
|
Sus-mesocolic |
0.621
|
Sub-mesocolic |
0.241
|
Pelvis |
0.855
|
Viscera |
0.044
|
ADP |
0.937
|
Title | Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
Time Frame | Pretherapeutic |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location at baseline : only eight patients had supra-diaphragmatic lesions and nine had ADP lesions. |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.813
|
Sus-mesocolic |
0.922
|
Sub-mesocolic |
0.794
|
Pelvis |
0.178
|
Viscera |
0.983
|
ADP |
0.974
|
Title | Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location |
---|---|
Description | Average intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging. The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
Time Frame | Pretherapeutic |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location at baseline: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions. |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.897
|
Sus-mesocolic |
0.960
|
Sub-mesocolic |
0.885
|
Pelvis |
0.302
|
Viscera |
0.991
|
ADP |
0.987
|
Title | Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual Intra-class Correlation (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted twice by radiologist and nuclear medicine specialist. |
Time Frame | After one cycle of chemotherapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable population |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.992
|
Sus-mesocolic |
0.884
|
Sub-mesocolic |
0.983
|
Pelvis |
0.998
|
Viscera |
0.317
|
ADP |
0.977
|
Title | Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location |
---|---|
Description | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging Positron Emission Tomography (PET) . The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
Time Frame | After one cycle of chemotherapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable population |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.996
|
Sus-mesocolic |
0.938
|
Sub-mesocolic |
0.991
|
Pelvis |
0.999
|
Viscera |
0.482
|
ADP |
0.989
|
Title | Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual intra-class correlation coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
Time Frame | After one cycle of chemoterapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable population |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.504
|
Sus-mesocolic |
0.882
|
Sub-mesocolic |
0.210
|
Pelvis |
0.699
|
Viscera |
0.486
|
ADP |
0.994
|
Title | Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
Time Frame | After one cycle of chemotherapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable population |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.670
|
Sus-mesocolic |
0.937
|
Sub-mesocolic |
0.347
|
Pelvis |
0.823
|
Viscera |
0.654
|
ADP |
0.997
|
Title | Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
Time Frame | After one cycle of chemotherapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location after one cycle of chemotherapy : only eight patients had supra-diaphragmatic lesions and nine had ADP lesions. |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.807
|
Sus-mesocolic |
0.340
|
Sub-mesocolic |
-0.080
|
Pelvis |
0.566
|
Viscera |
0.747
|
ADP |
0.863
|
Title | Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location |
---|---|
Description | Average intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
Time Frame | After one cycle of chemotherapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location after once cycle of chemotherapy: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions. |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.893
|
Sus-mesocolic |
0.507
|
Sub-mesocolic |
0.885
|
Pelvis |
0.723
|
Viscera |
0.855
|
ADP |
0.926
|
Title | Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
Time Frame | After four cycles of chemotherapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location after four cycles of chemotherapy: No patients with lesions in supra-diaphragmatic and viscera locations |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Sus-mesocolic |
0.923
|
Sub-mesocolic |
0.953
|
Pelvis |
0.962
|
ADP |
0.942
|
Title | Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location |
---|---|
Description | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
Time Frame | After four cycles of chemotherapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location after four cycles of chemotherapy: No patients with lesions in supra-diaphragmatic and viscera locations |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Sus-mesocolic |
0.960
|
Sub-mesocolic |
0.976
|
Pelvis |
0.981
|
ADP |
0.970
|
Title | Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
Time Frame | After four cycles of chemoterapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location after four cycles of chemotherapy: No patients with lesions in supra-diaphragmatic and viscera locations |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Sus-mesocolic |
0.957
|
Sub-mesocolic |
0.248
|
Pelvis |
0.998
|
ADP |
0.943
|
Title | Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by Location |
---|---|
Description | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
Time Frame | After four cycles of chemotherapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location after four cycles of chemotherapy: No patients with lesions in supra-diaphragmatic and viscera locations |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Sus-mesocolic |
0.978
|
Sub-mesocolic |
0.398
|
Pelvis |
0.999
|
ADP |
0.971
|
Title | Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
Time Frame | After four cycles of chemotherapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location after four cycles of chemotherapy: only eight patients had supra-diaphragmatic lesions (or ADP lesions). |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.961
|
Sus-mesocolic |
0.730
|
Sub-mesocolic |
0.862
|
Pelvis |
0.543
|
Viscera |
0.834
|
ADP |
1.000
|
Title | Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location |
---|---|
Description | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter of ADC functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other. |
Time Frame | After four cycles of chemotherapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location after four cycles of chemotherapy: only eight patients had supra-diaphragmatic lesions (or ADP lesions). |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.980
|
Sus-mesocolic |
0.844
|
Sub-mesocolic |
0.926
|
Pelvis |
0.703
|
Viscera |
0.910
|
ADP |
1.000
|
Title | Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter ADC of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | Pre-therapeutic |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location at baseline: only one patient with lesions in viscera locations |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
1.000
|
Sus-mesocolic |
0.998
|
Sub-mesocolic |
1.000
|
Pelvis |
0.997
|
Viscera |
1.000
|
ADP |
0.985
|
Title | Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location |
---|---|
Description | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | Pre-therapeutic |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location at baseline: only one patients with lesions in viscera locations and nine patients with sus-mesocolic lesion |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
1.000
|
Sus-mesocolic |
0.999
|
Sub-mesocolic |
1.000
|
Pelvis |
0.998
|
Viscera |
1.000
|
ADP |
0.992
|
Title | Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | Pre-therapeutic |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location at baseline : only nine patients with sub-mesocolic lesions. |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.987
|
Sus-mesocolic |
0.622
|
Sub-mesocolic |
0.493
|
Pelvis |
0.847
|
Viscera |
0.042
|
ADP |
0.934
|
Title | Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location |
---|---|
Description | Average Intra-class Correlation Coefficients by Location (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameters MTV of functional imaging Positron Emission Tomography. The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | Pre-therapeutic |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location at baseline : only nine patients with sub-mesocolic lesions. |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.993
|
Sus-mesocolic |
0.767
|
Sub-mesocolic |
0.660
|
Pelvis |
0.917
|
Viscera |
0.080
|
ADP |
0.966
|
Title | Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | Pretherapeutic |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location at baseline: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions. |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.747
|
Sus-mesocolic |
0.894
|
Sub-mesocolic |
0.452
|
Pelvis |
0.217
|
Viscera |
0.639
|
ADP |
0.961
|
Title | Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location |
---|---|
Description | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI) . The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | Pretherapeutic |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location at baseline: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions. |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.855
|
Sus-mesocolic |
0.944
|
Sub-mesocolic |
0.623
|
Pelvis |
0.356
|
Viscera |
0.780
|
ADP |
0.980
|
Title | Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUV max of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | After one cycle of chemoterapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.893
|
Sus-mesocolic |
0.998
|
Sub-mesocolic |
0.993
|
Pelvis |
0.997
|
Viscera |
0.317
|
ADP |
1.000
|
Title | Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location |
---|---|
Description | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | After once cycle of chemoterapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable population |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.943
|
Sus-mesocolic |
0.999
|
Sub-mesocolic |
0.996
|
Pelvis |
0.999
|
Viscera |
0.482
|
ADP |
0.482
|
Title | Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | After one cycle of chemoterapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable population |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.789
|
Sus-mesocolic |
0.898
|
Sub-mesocolic |
0.967
|
Pelvis |
0.329
|
Viscera |
0.193
|
ADP |
0.997
|
Title | Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location |
---|---|
Description | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | After once cycle of chemotherapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable population |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.882
|
Sus-mesocolic |
0.946
|
Sub-mesocolic |
0.983
|
Pelvis |
0.495
|
Viscera |
0.323
|
ADP |
0.999
|
Title | Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | After one cycle of chemotherapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location after one cycle of chemotherapy: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions. |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.607
|
Sus-mesocolic |
0.613
|
Sub-mesocolic |
-0.043
|
Pelvis |
0.451
|
Viscera |
0.792
|
ADP |
0.996
|
Title | Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location |
---|---|
Description | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | After one cycle of chemotherapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location after one cycle of chemotherapy: only eight patients had supra-diaphragmatic lesions and nine had ADP lesions. |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.755
|
Sus-mesocolic |
0.760
|
Sub-mesocolic |
-0.091
|
Pelvis |
0.622
|
Viscera |
0.884
|
ADP |
0.998
|
Title | Individual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | After four cycles of chemoterapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location after one cycle of chemotherapy: only one patients had sus-mesocolic lesions, nine sub-mesocolic lesion, one ADP lesions and no patient had visceral lesion. |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
1.000
|
Sus-mesocolic |
1.000
|
Sub-mesocolic |
1.000
|
Pelvis |
0.971
|
ADP |
1.000
|
Title | Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location |
---|---|
Description | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | After four cycles of chemoterapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable population. Only one patient had sus-mesocolic lesions, one patient ADP lesions, nine patients sub-mesocolic lesions and no patient had supra-diaphragmatic or viscera lesions |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Sus-mesocolic |
1.000
|
Sub-mesocolic |
1.000
|
Pelvis |
0.944
|
ADP |
1.000
|
Title | Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | After four cycle of chemoterapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location after four cycles of chemotherapy: No patients with lesions in the location of supra-diaphragmatic and viscera |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Sus-mesocolic |
0.794
|
Sub-mesocolic |
0.794
|
Pelvis |
0.975
|
ADP |
0.987
|
Title | Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location |
---|---|
Description | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | After four cycles of chemotherapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions by location after four cycles of chemotherapy: No patients with supra-diaphragmatic lesions or viscera lesions. |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Sus-mesocolic |
0.885
|
Sub-mesocolic |
0.885
|
Pelvis |
0.987
|
ADP |
0.993
|
Title | Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location |
---|---|
Description | Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | After four cycles of chemotherapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions (by location) after four cycles of chemotherapy: only eight patients had supra-diaphragmatic lesions (or ADP lesions) and nine had sus-mesocolic lesions. |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.930
|
Sus-mesocolic |
0.654
|
Sub-mesocolic |
0.767
|
Pelvis |
0.088
|
Viscera |
0.686
|
ADP |
0.804
|
Title | Intra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location |
---|---|
Description | Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist. |
Time Frame | After four cycles of chemotherapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
For patients with lesions (by location) after four cycles of chemotherapy: only eight patients had supra-diaphragmatic lesions (or ADP lesions) and nine had sus-mesocolic lesions. |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Supra-diaphragmatic |
0.964
|
Sus-mesocolic |
0.791
|
Sub-mesocolic |
0.868
|
Pelvis |
0.162
|
Viscera |
0.814
|
ADP |
0.891
|
Title | Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG) |
---|---|
Description | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 cycle of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value. |
Time Frame | After one cycle of chemotherapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable population |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVmax |
-0.091
|
Spearman correlation test statistics between CA125 and relative variation of PET parameter MTV |
-0.030
|
Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVN |
-0.212
|
Spearman correlation test statistics between CA125 and relative variation of PET parameter SUL |
-0.212
|
Spearman correlation test statistics between CA125 and relative variation of PET parameter TLG |
-0.164
|
Title | Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG) |
---|---|
Description | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy). In other words, without paying attention to assessment times and the location of the lesion, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyse. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value. |
Time Frame | After four cycles of chemotherapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and evaluable population |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVmax |
0.811
|
Spearman correlation test statistics between CA125 and relative variation of PET parameter MTV |
0.775
|
Spearman correlation test statistics between CA125 and relative variation of PET parameter SUVN |
0.811
|
Spearman correlation test statistics between CA125 and relative variation of PET parameter SUL |
0.811
|
Spearman correlation test statistics between CA125 and relative variation of PET parameter TLG |
0.775
|
Title | Spearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125 |
---|---|
Description | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. The appearance of new lesions (not present at baseline) has not been taken into account in the calculation of relative variations. The disappearance of pre-existing lesions at baseline has been taken into account in the calculation of relative variations. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles of chemotherapy and the pre-therapeutic value divided by the pre-therapeutic value. |
Time Frame | After one and four cycle(s) of chemotherapy (after 3 and 12 weeks) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Relative variations between pre-therapeutic and after one cycle of chemotherapy |
0.103
|
Relative variations between pre-therapeutic and after four cycles of chemotherapy |
-0.571
|
Title | Complete Surgery Resection |
---|---|
Description | |
Time Frame | Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Yes |
10
90.9%
|
No |
0
0%
|
Title | Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1 |
---|---|
Description | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). |
Time Frame | After one cycle of chemotherapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Partial response |
-25.4
(33.1)
|
Stable disease |
-9.6
(29.8)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Functional Imaging |
---|---|---|
Comments | ||
Type of Statistical Test | Non-Inferiority | |
Comments | alpha=5% | |
Statistical Test of Hypothesis | p-Value | 0.602 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 0.273 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1 |
---|---|
Description | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. RRelative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). |
Time Frame | After four cycles of chemotherapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Relative variations of SUVmax by response : 8 partial response and 2 stable disease |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Partial response |
-67.3
(29.3)
|
Stable disease |
-11.3
(31.1)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Functional Imaging |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | alpha=5% | |
Statistical Test of Hypothesis | p-Value | 0.067 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 3.361 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1 |
---|---|
Description | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). |
Time Frame | After four cycles of chemotherapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Partial response |
-94.7
(11.4)
|
Stable disease |
12.9
(52.9)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Functional Imaging |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | alpha=5% | |
Statistical Test of Hypothesis | p-Value | 0.036 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 4,390 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1 |
---|---|
Description | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). |
Time Frame | After one cycle of chemotherapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Relative variations of MTV by response : 8 partial response and 2 stable disease |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Partial response |
-38.5
(47.6)
|
Stable disease |
-3.3
(5.4)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Functional Imaging |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | alpha=5% | |
Statistical Test of Hypothesis | p-Value | 0.296 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 1.091 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1 |
---|---|
Description | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). |
Time Frame | After one cycle of chemotherapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Relative variations of SUVN by response : 8 partial response and 2 stable disease |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Partial response |
-21.8
(28.8)
|
Stable disease |
-15.6
(22.1)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Functional Imaging |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | alpha=5% | |
Statistical Test of Hypothesis | p-Value | 0.794 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 0.068 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1 |
---|---|
Description | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). |
Time Frame | After four cycles of chemotherapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Relative variations of SUVN by response : 8 partial response and 2 stable disease |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Partial response |
-65.2
(29.4)
|
Stable disease |
-16.2
(30.2)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Functional Imaging |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | alpha=5% | |
Statistical Test of Hypothesis | p-Value | 0.067 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 3.361 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1 |
---|---|
Description | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). |
Time Frame | After one cycle of chemotherapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Relative variations of TLG by response : 8 partial response and 2 stable disease |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Partial response |
-63.5
(52.4)
|
Stable disease |
-15.2
(12.9)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Functional Imaging |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | alpha=5% | |
Statistical Test of Hypothesis | p-Value | 0.296 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 1,091 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1 |
---|---|
Description | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). |
Time Frame | After four cycles of chemotherapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Relative variations of TLG by response : 8 partial response and 2 stable disease |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Partial response |
-97.7
(9.4)
|
Stable disease |
-7.5
(18.2)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Functional Imaging |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | alpha=5% | |
Statistical Test of Hypothesis | p-Value | 0.036 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 4.390 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1 |
---|---|
Description | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). |
Time Frame | After one cycle of chemotherapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Relative variations of TLG by response : 8 partial response and 2 stable disease |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Partial response |
-24.9
(31.9)
|
Stable disease |
-21.8
(11.4)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Functional Imaging |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | alpha=5% | |
Statistical Test of Hypothesis | p-Value | 0.794 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 0.068 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1 |
---|---|
Description | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). |
Time Frame | After four cycles of chemotherapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Relative variations of TLG by response : 8 partial response and 2 stable disease |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Partial response |
-66.9
(29.0)
|
Stable disease |
-14.7
(33.8)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Functional Imaging |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | alpha=5% | |
Statistical Test of Hypothesis | p-Value | 0.036 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 4.390 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Descriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1 |
---|---|
Description | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). |
Time Frame | After one cycle of chemotherapy, 3 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Relative variations of ADC by response : 8 partial response and 2 stable disease |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Partial response |
9.3
(209.7)
|
Stable disease |
4.3
(25.1)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Functional Imaging |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | alpha=5% | |
Statistical Test of Hypothesis | p-Value | 0.602 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 0.273 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Descriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1 |
---|---|
Description | In this section, only the maximum values of the PET parameters (SUVmax, MTV, SUVN, SUL, TLG) and the minimum values of the MRI parameters (ADC) of each patient were taken into account for all lesions present at each evaluation time (pre-therapy, after 1 cycle of chemotherapy, after 4 cycles of chemotherapy. In other words, for each patient, the highest value of SUVmax, MTV, SUVN, SUL, TLG and the lowest ADC value was taken into account in the analyses. Relative variations has been calculated as the difference between the values collected after 1 or 4 cycles (C1 or C4) of chemotherapy and the pre-therapeutic value (C0) divided by the pre-therapeutic value (C0). |
Time Frame | After four cycles of chemotherapy, 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Relative variations of SUVmax by response : 8 partial response and 2 stable disease |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Partial response |
38.6
(274.5)
|
Stable disease |
-18.0
(40.1)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Functional Imaging |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | alpha=5% | |
Statistical Test of Hypothesis | p-Value | 0.192 |
Comments | ||
Method | Kruskal-Wallis | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 1.705 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Peritoneal Extent Assessed by Fagotti Score Using MRI Data |
---|---|
Description | The Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of subscale values corresponds to Fagotti score. |
Time Frame | Pre-therapeutic |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
4 |
2
18.2%
|
8 |
4
36.4%
|
10 |
2
18.2%
|
12 |
1
9.1%
|
Missing |
1
9.1%
|
Title | Peritoneal Extent Assessed by Fagotti Score Using MRI Data |
---|---|
Description | TThe Fagotti score ranges from 0 to 14 and is used to evaluate the peritoneal damage of patients. This score was collected during pretherapy and after 4 cycles of chemotherapy. The higher the stage number is, the further the cancer has spread. The Fagotti questionnaire has 7 items. A subscale value of 0 or 2 is assigned depending on whether the disease is present in those specific sites : large omentum, peritoneal carcinosis , diaphragmatic carcinosis, mesenteric retraction, intestinal infiltration, stomach infiltration,liver metastases. The sum of subscales corresponds to Fagotti score. |
Time Frame | Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
0 |
1
9.1%
|
2 |
1
9.1%
|
4 |
2
18.2%
|
6 |
2
18.2%
|
8 |
3
27.3%
|
10 |
1
9.1%
|
Title | Overall Survival |
---|---|
Description | |
Time Frame | 10 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
Number (95% Confidence Interval) [percentage of patients] |
90
|
Title | Progression-free Survival as Per RECIST v1.1 |
---|---|
Description | |
Time Frame | 9, 13, 14 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Functional Imaging |
---|---|
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval |
Measure Participants | 10 |
9 months |
90.0
|
13 months |
78.8
|
14 months |
67.5
|
Adverse Events
Time Frame | All adverse events are recorded from the first visit (J0 inclusion) until 4 weeks after the third PET/MRI examination. Beyond this period, only SAE likely to be related to the research or the medical device or to the procedure of implementation of the medical device are reported. | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Functional Imaging | |
Arm/Group Description | A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT) Functional Imaging previous the second course: Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1 Functional Imaging previous the surgery: Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval | |
All Cause Mortality |
||
Functional Imaging | ||
Affected / at Risk (%) | # Events | |
Total | 1/11 (9.1%) | |
Serious Adverse Events |
||
Functional Imaging | ||
Affected / at Risk (%) | # Events | |
Total | 3/11 (27.3%) | |
Blood and lymphatic system disorders | ||
Anemia | 1/11 (9.1%) | 1 |
Gastrointestinal disorders | ||
Colonic obstruction | 1/11 (9.1%) | 1 |
Vomiting | 1/11 (9.1%) | 1 |
Infections and infestations | ||
Sepsis | 1/11 (9.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
Functional Imaging | ||
Affected / at Risk (%) | # Events | |
Total | 11/11 (100%) | |
Blood and lymphatic system disorders | ||
Anemia | 3/11 (27.3%) | 3 |
Cardiac disorders | ||
Sinus tachycardia | 1/11 (9.1%) | 1 |
Gastrointestinal disorders | ||
Abdominal pain | 1/11 (9.1%) | 1 |
Ascites | 2/11 (18.2%) | 2 |
Bloating | 1/11 (9.1%) | 1 |
Constipation | 2/11 (18.2%) | 2 |
Diarrhea | 2/11 (18.2%) | 2 |
Nausea | 2/11 (18.2%) | 2 |
General disorders | ||
Fatigue | 2/11 (18.2%) | 2 |
Fever | 2/11 (18.2%) | 2 |
Immune system disorders | ||
Allergic reaction | 2/11 (18.2%) | 4 |
Infections and infestations | ||
Bronchial infection | 2/11 (18.2%) | 2 |
Enterocolitis infectious | 1/11 (9.1%) | 1 |
Peritoneal infection | 1/11 (9.1%) | 1 |
Urinary tract infection | 2/11 (18.2%) | 2 |
Investigations | ||
Creatinine increased | 1/11 (9.1%) | 1 |
Neutrophil count decreased | 1/11 (9.1%) | 1 |
Platelet count decreased | 1/11 (9.1%) | 1 |
Musculoskeletal and connective tissue disorders | ||
Musculoskeletal and connective tissue disorder - Other, specify | 1/11 (9.1%) | 1 |
Myalgia | 1/11 (9.1%) | 1 |
Nervous system disorders | ||
Peripheral sensory neuropathy | 2/11 (18.2%) | 2 |
Renal and urinary disorders | ||
Cystitis noninfective | 1/11 (9.1%) | 1 |
Renal and urinary disorders - Other, specify | 2/11 (18.2%) | 2 |
Reproductive system and breast disorders | ||
Reproductive system and breast disorders - Other, specify | 1/11 (9.1%) | 1 |
Vaginal hemorrhage | 1/11 (9.1%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||
Pleural effusion | 1/11 (9.1%) | 1 |
Skin and subcutaneous tissue disorders | ||
Alopecia | 3/11 (27.3%) | 3 |
Nail discoloration | 1/11 (9.1%) | 1 |
Vascular disorders | ||
Hypertension | 2/11 (18.2%) | 2 |
Thromboembolic event | 1/11 (9.1%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Anne Laure Cazeau, Coordinating Investigator |
---|---|
Organization | Institute Bergonie |
Phone | 0556337860 |
A.Cazeau@bordeaux.unicancer.fr |
- IB 2013-03