IMOVA: Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging

Sponsor
Institut Bergonié (Other)
Overall Status
Completed
CT.gov ID
NCT02792959
Collaborator
Roche Pharma AG (Industry), Ligue contre le cancer, France (Other)
11
1
1
36
0.3

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
  • Device: Functional Imaging previous the second course
  • Device: Functional Imaging previous the surgery
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

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging (Fusion MRI and FDG-PET-CT)
Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Jan 1, 2017
Actual Study Completion Date :
Aug 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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

  1. 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.

  2. 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.

  3. 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.

  4. Complete Surgery Resection [Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery]

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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.

  18. 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.

  19. Overall Survival [10 months]

  20. Progression-free Survival as Per RECIST v1.1 [9, 13, 14 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Epithelial ovarian carcinoma, fallopian tube, or primary peritoneal carcinoma FIGO IIIC-IV histologically confirmed by biopsy and documented stage and untreated

  • Pre-treatment abdominopelvic PET-CT and MRI within 4 weeks before neoadjuvant chemotherapy.

  • During laparoscopy performed by an experienced surgeon in the treatment of ovarian cancer, patient considered ineligible for tumor cell kill at the outset.

  • A life expectancy of greater than three months

  • An eligible patient for Paclitaxel and Carboplatine based chemotherapy.

  • 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:

Publications

None provided.
Responsible Party:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT02792959
Other Study ID Numbers:
  • IB 2013-03
First Posted:
Jun 8, 2016
Last Update Posted:
Apr 21, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

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

1. Primary Outcome
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
2. Primary Outcome
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
3. Primary Outcome
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
4. Primary Outcome
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
5. Primary Outcome
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
6. Primary Outcome
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
7. Primary Outcome
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
8. Primary Outcome
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
9. Primary Outcome
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
10. Primary Outcome
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
11. Primary Outcome
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
12. Primary Outcome
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
13. Primary Outcome
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
14. Primary Outcome
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
15. Primary Outcome
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
16. Primary Outcome
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
17. Primary Outcome
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
18. Primary Outcome
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
19. Primary Outcome
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
20. Primary Outcome
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
21. Primary Outcome
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
22. Primary Outcome
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
23. Primary Outcome
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
24. Primary Outcome
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
25. Primary Outcome
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
26. Primary Outcome
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
27. Primary Outcome
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
28. Primary Outcome
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
29. Primary Outcome
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
30. Primary Outcome
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
31. Primary Outcome
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
32. Primary Outcome
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
33. Primary Outcome
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
34. Primary Outcome
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
35. Primary Outcome
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
36. Primary Outcome
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
37. Secondary Outcome
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
38. Secondary Outcome
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
39. Secondary Outcome
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
40. Secondary Outcome
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%
41. Secondary Outcome
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
42. Secondary Outcome
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
43. Secondary Outcome
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
44. Secondary Outcome
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
45. Secondary Outcome
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
46. Secondary Outcome
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
47. Secondary Outcome
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
48. Secondary Outcome
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
49. Secondary Outcome
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
50. Secondary Outcome
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
51. Secondary Outcome
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
52. Secondary Outcome
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
53. Secondary Outcome
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%
54. Secondary Outcome
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%
55. Secondary Outcome
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
56. Secondary Outcome
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

[Not Specified]

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
Email A.Cazeau@bordeaux.unicancer.fr
Responsible Party:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT02792959
Other Study ID Numbers:
  • IB 2013-03
First Posted:
Jun 8, 2016
Last Update Posted:
Apr 21, 2021
Last Verified:
Mar 1, 2021