Prospective Evaluation of 68Ga-FAPI PET in Biliary Cancers

NCT07337850 | Recruiting DMC

• 2 other identifiers: Study no:- 44556429
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gall Bladder Cancer; Intrahepatic Cholangiocarcinoma (Icc)

Keywords

FAPI PET/CT; Gallium-68 FAPI; Biliary Tract Cancer; Gallbladder Cancer; Cholangiocarcinoma; Intrahepatic Cholangiocarcinoma (iHCC)

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of Ga-68 FAPI PET/CT for detection of metastatic or recurrent disease (measured as sensitivity and specificity)

  1 Year

Interventions

gallium-68-Fibroblast Activation Protein Inhibitor DIAGNOSTIC_TEST

Gallium-68 Fibroblast Activation Protein Inhibitor (Ga-68 FAPI) is a radiolabeled molecular imaging tracer used for PET/CT imaging. It targets Fibroblast Activation Protein (FAP), which is highly expressed on cancer-associated fibroblasts within the tumor microenvironment in many epithelial malignancies, including biliary tract cancers. Ga-68 FAPI PET/CT provides high tumor uptake and improved tumor-to-background contrast, which may enhance detection of primary tumors, nodal disease, and distant metastases. It has demonstrated potential advantages over 18F-FDG PET/CT in sensitivity and diagnostic accuracy for staging and recurrence assessment.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult male and female patients (≥18 years) with suspected or confirmed biliary tract cancers, including intrahepatic cholangiocarcinoma (iHCC) and gallbladder cancer (GBC). Eligible participants include individuals with upfront advanced disease (suspected T3/T4 tumors, N1 nodal involvement, or vascular involvement), patients with residual or node-positive incidental gallbladder cancer (iGBC), and those with suspected post-treatment recurrence based on biochemical markers or radiologic evaluation.

You may qualify if:

• 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)

You may not qualify if:

• Informed consent withdrawal
• Concurrent Malignancy

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Dr.Shraddha Patkar

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Publications (40)

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MeSH Terms

Conditions

Gallbladder Neoplasms; Cholangiocarcinoma; Cirrhosis, Familial, with Pulmonary Hypertension; Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Dr.Shraddha Patkar

  Tata Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr.Shraddha Patkar

CONTACT

+91 9820074818; drshraddhapatkar@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: January 13, 2026
• Study Start: September 25, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)