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Clinical trial Recruiting at 1 site Observational Ages 18 to 90

68Ga‑FAPI PET/CT imaging for biliary tract cancers

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

Run by Tata Memorial Centre · NCT07337850 · Data updated 2026-11-12

We will test whether 68Ga‑FAPI PET/CT scans can find and stage gallbladder cancer and intrahepatic cholangiocarcinoma more accurately than standard FDG PET/CT in adults with suspected or known disease.

Quick facts

Study typeObservational
Ages18 Years to 90 Years
SexAll
Enrollment60 (estimated)
SponsorTata Memorial Centre
Academic / other
Locations1 site (Mumbai, Maharashtra)
StatusRecruiting
StartedSeptember 25, 2024
Main results expectedMarch 2026
Study endsMarch 2026
Registry record updatedJanuary 13, 2026
Trial IDNCT07337850 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 or older with suspected or confirmed biliary tract cancers (gallbladder cancer or intrahepatic cholangiocarcinoma) who require staging or evaluation for suspected post-treatment recurrence and can provide informed consent.

Probably not a fit

Patients with an active concurrent malignancy, those who withdraw consent, or patients whose disease is already definitively staged by standard imaging may not receive additional benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study comparing Ga‑68 FAPI PET/CT with standard 18F‑FDG PET/CT for initial staging and suspected recurrence in biliary tract cancers. Researchers will measure diagnostic performance (sensitivity, specificity, PPV, NPV) and semi-quantitative PET metrics like SUVmax and metabolic volume, using histopathology or follow-up imaging as the reference standard. The study focuses on detecting primary tumors, nodal involvement, liver and peritoneal metastases and estimating any added diagnostic yield of FAPI over FDG. Results will be used to see whether FAPI imaging could change staging or clinical decision-making and reduce the need for invasive procedures.

Why it matters

Potential benefit: If successful, FAPI PET/CT could detect more small primary tumors, lymph node and liver or peritoneal metastases and lead to more accurate staging to guide treatment choices.

How similar studies have gone: Early studies in biliary and other desmoplastic tumors have reported improved lesion detectability and tumor‑to‑background contrast with Ga‑68 FAPI PET/CT compared with FDG PET/CT, but larger prospective data are still limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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's running

  • Dr.Shraddha Patkar
    Mumbai, Maharashtra, India     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Gall Bladder Cancer 11Intrahepatic Cholangiocarcinoma (Icc) 19Tata Memorial Centre 37
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.