Prospective Evaluation of 68Ga-FAPI PET in Biliary Cancers

Recruiting now

Conditions studied: Gall Bladder Cancer, Intrahepatic Cholangiocarcinoma (Icc)

In brief

The goal of this prospective observational study is to evaluate whether Gallium-68 Fibroblast Activation Protein Inhibitor (FAPI) PET/CT can improve detection, staging, and recurrence assessment in adult patients (≥18 years) with suspected or confirmed biliary tract cancers, including gallbladder cancer, cholangiocarcinoma, and post-treatment suspected recurrence. The main question(s) this study aims to answer are: Can FAPI PET/CT provide greater sensitivity, specificity and diagnostic accuracy for primary tumors, nodal disease, and metastatic lesions compared to standard FDG PET/CT? Does FAPI PET/CT offer additional diagnostic yield that may affect clinical decision-making and staging, potentially reducing need for invasive staging procedures? Researchers will compare FAPI PET/CT with FDG PET/CT to see if FAPI improves detection of metastatic or recurrent disease, especially peritoneal or liver metastasis and lymph node involvement. Participants will: Provide written informed consent. Undergo FAPI PET/CT imaging (baseline and/or at suspected biochemical or radiologic recurrence). Have quantitative imaging parameters evaluated (SUVmax, tumor-to-liver ratios, metabolic volume). May undergo comparison with FDG PET/CT and/or follow-up imaging or histopathology as gold standard.

Key facts

Study ID
NCT07337850
Run by
Tata Memorial Centre
People needed
60
Starts
2024-09-25
Expected to finish
2026-03-01
Last updated by the study team
2026-01-13

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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