Using Ga68-FAPI-46 PET/CT to assess peritoneal carcinomatosis before surgery
Ga68-labeled Fibroblast Activation Protein Inhibitor-46 (Ga68-FAPI-46) PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis
This study is testing a new type of imaging scan to see if it can better detect cancer spread in the abdomen before surgery for people with colorectal and ovarian cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jules Bordet Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Brussels) |
| Trial ID | NCT06061874 on ClinicalTrials.gov |
What this trial studies
This clinical imaging trial evaluates the effectiveness of Ga68-FAPI-46 PET/CT in accurately assessing peritoneal carcinomatosis in patients with colorectal and ovarian cancer. The study aims to correlate the imaging findings with intraoperative histopathology results to determine the accuracy of this novel radiotracer. Ga68-FAPI-46 targets fibroblast activation protein in the tumor microenvironment, potentially offering improved sensitivity over traditional imaging methods. Participants will undergo PET/CT scans prior to scheduled cytoreductive surgery.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed colorectal or ovarian cancer and known or suspected peritoneal metastases scheduled for curative surgery.
Not a fit: Patients with non-resectable extra-abdominal metastases or significant chronic inflammatory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate preoperative assessments, improving surgical outcomes for patients with peritoneal carcinomatosis.
How similar studies have performed: While the use of Ga68-FAPI PET/CT is a novel approach, similar imaging techniques targeting tumor microenvironments have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Brussels
- Institut Jules Bordet — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Patrick Flamen — Jules Bordet Institute
- Study coordinator: Loubna Taraji Schiltz
- Email: loubna.taraji@hubruxelles.be
- Phone: +32 (0) 2 541 37 81
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.