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FAPI PET scans to find biliary tract cancers in adults

Tests a new PET scan for finding gallbladder and bile duct cancers.

Plain-language title generated from the registry record
Registry title: Prospective Evaluation of 68Ga-FAPI PET in Biliary Cancers

Key facts

Where
Mumbai, IndiaSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 90 years old?

Source: NCT07337850, who can take part

Where in India

  • Dr.Shraddha PatkarMumbai, IndiaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Tata Memorial Centre
Trial code
NCT07337850
Record updated
13 January 2026
Original description
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.Read full original descriptionShow less

FAP 2: Utility of Gallium-68-Fibroblast Activation Protein Inhibitor (FAPI) PET in Biliary Tract Cancers: A Prospective Study

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.

Inclusion: 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: Concurrent Malignancy; Informed consent withdrawal.

ClinicalTrials.gov NCT07337850