ThorPET: Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study
Study Details
Study Description
Brief Summary
In this pilot study we propose the intraoperative use of a high-resolution PET-CT imaging system which can assess resection margins and lymph node status in the operating room. This will allow for a faster and stepwise assessment (estimated to be under 10 minutes per specimen), enabling the surgeon to decide on subsequent surgical steps after each previous assessment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 18F-FDG AURA10 Specimen Imager Intravenous injection of radiotracer (18F-FDG) (study-specific) Thoracic surgery (standard-of-care; not study-specific) High-resolution specimen imaging using the AURA10 PET-CT specimen imager (study-specific) Postoperative histopathological analysis of specimen (standard-of-care) |
Device: AURA10 Specimen Imager
High-resolution specimen imaging using the AURA10 PET-CT specimen imager during thoracic surgery.
|
Outcome Measures
Primary Outcome Measures
- Perioperative success in imaging utilizing AURA10 PET-CT Specimen Imager [Perioperative]
A measure of perioperative success in imaging 18F-FDG- uptake in resected specimens obtained during thoracic surgery utilizing a high-resolution PET-CT-scanner.
Secondary Outcome Measures
- Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected mediastinal or thoracic lymph nodes in terms of nodal staging. [Perioperative]
- Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of bronchial margin assessment. [Perioperative]
- Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of lung parenchyma margin assessment [Perioperative]
- Correlation between 18F-FDG uptake in the resected specimens and histopathological characteristics of the tumor, such as the type, grade, or stage of the tumor. [Perioperative]
- Measure signal-to-noise ratio on post-processed PET-CT specimen images. [Perioperative]
- Comparison of lesion dimensions (e.g. delineation based on percentage of SUVmax, tumor-to-background ratios based on SUVpeak). [Perioperative]
- Occupational radiation exposure (µSv) to the staff in the operating room related to this study. [Perioperative]
- Correlation of high-resolution 18F-FDG-PET-CT images of lamellas of the resected specimen with histopathological whole-slide images. [Perioperative]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is 18 years of age or older.
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Patient with suspected or confirmed lung malignancies
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Patient is indicated to undergo thoracic surgery.
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Patient is estimated to be compliant for study participation by the investigator.
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Patient has freely given his/her informed consent to participate in this study.
Exclusion Criteria:
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Patient has general or local contra-indications for thoracic surgery.
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Patient has active infection.
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Blood glucose level over 200 mg/dL on the day of surgery.
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Pregnancy or lactation.
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Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Ghent | Ghent | Belgium | 9000 |
Sponsors and Collaborators
- University Hospital, Ghent
- XEOS Medical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Goker M, Marcinkowski R, Van Bockstal M, Keereman V, Van Holen R, Van Dorpe J, Vandenberghe S, Brans B, Depypere H, Van den Broecke R. 18F-FDG micro-PET/CT for intra-operative margin assessment during breast-conserving surgery. Acta Chir Belg. 2020 Oct;120(5):366-374. doi: 10.1080/00015458.2020.1774163. Epub 2020 Jun 15.
- Piron S, De Man K, Van Laeken N, D'Asseler Y, Bacher K, Kersemans K, Ost P, Decaestecker K, Deseyne P, Fonteyne V, Lumen N, Achten E, Brans B, De Vos F. Radiation Dosimetry and Biodistribution of 18F-PSMA-11 for PET Imaging of Prostate Cancer. J Nucl Med. 2019 Dec;60(12):1736-1742. doi: 10.2967/jnumed.118.225250. Epub 2019 Apr 26.
- ThorPET/202301