68Ga‑FAPI PET/CT imaging for biliary tract cancers
FAP 2: Utility of Gallium-68-Fibroblast Activation Protein Inhibitor (FAPI) PET in Biliary Tract Cancers: A Prospective Study
Tata Memorial Centre · NCT07337850
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 type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Tata Memorial Centre (other) |
| Locations | 1 site (Mumbai, Maharashtra) |
| Trial ID | NCT07337850 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Mumbai, Maharashtra
- Dr.Shraddha Patkar — Mumbai, Maharashtra, India (RECRUITING)
Study contacts
- Principal investigator: Dr.Shraddha Patkar — Tata Memorial Hospital
- Study coordinator: Dr.Shraddha Patkar
- Email: drshraddhapatkar@gmail.com
- Phone: +91 9820074818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gall Bladder Cancer, Intrahepatic Cholangiocarcinoma, FAPI PET/CT, Gallium-68 FAPI, Biliary Tract Cancer, Gallbladder Cancer, Cholangiocarcinoma