Ga68-FAPI-46 PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis
Ga68-labeled Fibroblast Activation Protein Inhibitor-46 (Ga68-FAPI-46) PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis
Jules Bordet Institute
80 participants
May 30, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria5
- 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.
Interventions
The radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is applied intravenously for molecular imaging of FAP expression with FAPI PET/CT.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06061874