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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form obtained before any study-specific screening procedures. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DIAGNOSTIC_TEST

FAPI PET/CT

The radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is applied intravenously for molecular imaging of FAP expression with FAPI PET/CT.

Locations (1)

Institut Jules Bordet
Brussels, Belgium