Prospective Evaluation of 68Ga-FAPI PET in Biliary Cancers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorTata Memorial Centre
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Suspected biliary tract cancers- iHCC and GBC
Male and females ≥ 18 years;
Upfront advanced (suspected T3 ,T4, N1, vascular involvement)
iGBC (residual, N1)
Disqualifiers
Informed consent withdrawal
Concurrent Malignancy
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
gallium-68-Fibroblast Activation Protein Inhibitor
Diagnostic testGallium-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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Diagnostic accuracy of Ga-68 FAPI PET/CT for detection of metastatic or recurrent disease (measured as sensitivity and specificity)
Time frame
1 YearSponsors and contacts
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Source ClinicalTrials.gov