Actively Recruiting
Ga68-labeled Fibroblast Activation Protein Inhibitor-46 (Ga68-FAPI-46) PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis
Led by Jules Bordet Institute · Updated on 2025-03-31
80
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of a new imaging method using a radiotracer called Ga68-FAPI-46 in PET/CT scans to assess peritoneal carcinomatosis in patients with colorectal and ovarian cancer. This phase II, non-randomized clinical imaging trial studies a protein called Fibroblast Activation Protein (FAP), found in the tumor environment. The goal is to see how well this imaging technique detects cancer spread before surgery compared to current methods and surgical findings. The study involves patients who have or are suspected to have peritoneal metastases and are scheduled for complete cytoreductive surgery. Participants receive the Ga68-FAPI-46 radiotracer intravenously, followed by PET/CT imaging. Those undergoing neoadjuvant chemotherapy will have scans before and after their treatment. The imaging results will be compared with surgical and histopathological findings to evaluate the method's accuracy. During the study, participants will undergo imaging scans and surgical procedures as part of their standard care. Researchers will compare the cancer spread scores from the Ga68-FAPI-46 PET/CT scans with those obtained during surgery and standard imaging. They will also assess how chemotherapy affects the expression of the target protein in tumors. The study lasts up to two years, including follow-up examinations after surgery and chemotherapy.
CONDITIONS
Brief Title
Ga68-FAPI-46 PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 Performance status 2.
- Signed written informed consent obtained before any study-specific screening procedures.
You will not qualify if you...
- Non-resectable extra-abdominal metastasis and/or more than 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.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several weeks before surgery
Participants undergo Ga68-FAPI PET/CT imaging to assess peritoneal involvement before their planned surgery. Those receiving neoadjuvant chemotherapy have imaging both before and after chemotherapy.
1 to 2 visits depending on chemotherapy status
Duration - Until discharge after surgery
Participants undergo complete cytoreductive surgery to remove peritoneal metastases.
1 in-person surgical visit plus immediate post-operative care
Duration - Up to 2 years after surgery
Participants are monitored through post-surgical pathological examination and follow-up imaging to assess the accuracy of Ga68-FAPI PET/CT over time.
Follow-up visits as scheduled by the clinical team
Trial Site Locations
Total: 1 location
1
Institut Jules Bordet
Brussels, Belgium
Actively Recruiting
Research Team
L
Loubna Taraji Schiltz
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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