Status:
RECRUITING
Ga68-FAPI-46 PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis
Lead Sponsor:
Jules Bordet Institute
Conditions:
Cancer
Peritoneal Carcinomatosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 (Fibrob...
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, radiolab...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06061874
Start Date
May 30 2023
End Date
December 1 2025
Last Update
March 31 2025
Active Locations (1)
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1
Institut Jules Bordet
Brussels, Belgium