Ga68-FAPI-46 PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis
- Conditions
- Peritoneal CarcinomatosisCancer
- Interventions
- Diagnostic Test: FAPI PET/CT
- Registration Number
- NCT06061874
- Lead Sponsor
- Jules Bordet Institute
- Brief Summary
This is a prospective, phase II, non-randomized clinical imaging trial. Ga68-FAPI-46 is a novel radiotracer used in PET/CT imaging, targeting a protein of the tumor microenvironment called FAP (Fibroblast activation protein).
The aim of the study is to assess the accuracy of Ga68-FAPI-46 PET/CT for preoperative assessment of peritoneal carcinomatosis in colorectal and ovarian cancer.
- Detailed Description
Fibroblast activation protein (FAP) is a type II transmembrane glycoprotein expressed on the surface of cancer-associated fibroblasts (CAFs) in the stroma of various tumor entities. Recently, radiolabeled molecules targeting the FAP, called FAP inhibitors (FAPI) labelled with Gallium-68, have been developed for molecular imaging with PET/CT (positron emission tomography/computed tomography). This radiotracer often presents a higher cancer lesion detectability than F18-FDG (fluorodeoxyglucose), partly thanks to its higher tumour-to-background ratio achieved by a low background activity, particularly in the brain, abdominal cavity and liver. These advantages have resulted in a superior sensitivity of Ga68-FAPI PET/CT over F18-FDG and higher SUV (standardized uptake value) in evaluating various types of cancer. In this context, Ga68-FAPI PET/CT seems promising to further study as a clinical imaging modality for preoperative assessment of peritoneal carcinomatosis.
In this study, the investigators correlate Ga68-FAPI PET/CT findings in terms of peritoneal involvement with intraoperative findings based on histopathology and try to find out how accurate Ga68-FAPI PET/CT is for the preoperative assessment of peritoneal carcinomatosis.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- Histologically proven colorectal and ovarian cancer.
- Known or suspected peritoneal metastases from the tumour of origin.
- Scheduled for peritoneal complete cytoreductive surgery with curative intent with or without neoadjuvant chemotherapy.
- ECOG (Eastern Cooperative Oncology Group) Performance status ≤2.
- Signed written informed consent obtained before any study-specific screening procedures.
- Non-resectable extra-abdominal metastasis and/or >3 hepatic metastases on standard work-up
- Known chronic inflammatory conditions including the intestinal system (eg. inflammatory bowel disease, Crohn's disease)
- Pregnant and lactating women
- Previous or concurrent malignancy diagnosed within the last 3 years except adequately treated in situ carcinoma of the cervix uteri and basal or squamous cell skin cancer.
- Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FAPI PET/CT FAPI PET/CT Patients with known or suspected peritoneal metastases from colorectal and ovarian cancers scheduled for complete cytoreductive surgery undergo FAPI PET/CT before the planned surgery. In the target population, patients receiving neoadjuvant chemotherapy undergo FAPI PET/CT both before and after chemotherapy.
- Primary Outcome Measures
Name Time Method Correlation of the Ga68-FAPI PET/CT derived PCI (peritoneal cancer index) score with the intraoperative PCI based on histopathology of resected specimen (the reference standard) Through completion of post-surgical pathological examination, up to 2 years since the study initiation Intraoperative PCI validated by histopathology performed on resected peritoneal metastases obtained during peritoneal cytoreductive surgery/explorative laparoscopy or laparotomy will be correlated with Ga68-FAPI PET/CT derived PCI.
- Secondary Outcome Measures
Name Time Method Assessment of the impact of neoadjuvant chemotherapy on the FAPI expression of target lesions at baseline. Through completion of post-neoadjuvant chemotherapy FAPI PET examination,up to 2 years since the study initiation Subgroup: Patients receiving neoadjuvant chemotherapy Treatment-induced change in the total peritoneal tumor volume and uptake intensity of FAPI on PET/CT will be assessed and correlated to histopathological findings.
Comparison of PCI obtained with Ga68-FAPI PET/CT to the PCI calculated on standard preoperative imaging. Through completion of imaging examinations, up to 2 years since the study initiation PCI calculated on standard preoperative imaging (MRI and FDG PET/CT) will be correlated with Ga68-FAPI PET/CT derived PCI.
Related Research Topics
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Trial Locations
- Locations (1)
Institut Jules Bordet
🇧🇪Brussels, Belgium