Prospective Evaluation of 68Ga-FAPI PET in Biliary Cancers
Recruiting · NCT07337850 · Observational (researchers observe without assigning treatment) · Lead sponsor: Tata Memorial Centre
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Suspected biliary tract cancers- iHCC and GBC
- Male and females ≥ 18 years;
- Upfront advanced (suspected T3 ,T4, N1, vascular involvement)
- iGBC (residual, N1)
- Suspected post-treatment recurrence (biochemical or radiological)
Exclusion criteria
- Informed consent withdrawal
- Concurrent Malignancy
Where it is running
1 location listed.
- Dr.Shraddha Patkar - Mumbai, Maharashtra, India