RecruitingNCT07337850

Prospective Evaluation of 68Ga-FAPI PET in Biliary Cancers

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


Sponsor

Tata Memorial Centre

Enrollment

60 participants

Start Date

Sep 25, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a specialised type of PET scan using a radioactive tracer called 68Ga-FAPI to better detect and stage cancers of the bile ducts and gallbladder. The goal is to see whether this scan gives doctors better information than standard imaging when planning treatment. **You may be eligible if...** - You are 18 or older - You have suspected or confirmed bile duct cancer (intrahepatic cholangiocarcinoma) or gallbladder cancer - Your cancer appears to be locally advanced on initial scans, or there is suspicion of recurrence after treatment **You may NOT be eligible if...** - You withdraw your consent - You have another active cancer at the same time Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTgallium-68-Fibroblast Activation Protein Inhibitor

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.


Locations(1)

Dr.Shraddha Patkar

Mumbai, Maharashtra, India

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NCT07337850


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