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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
India
Dr.Shraddha Patkar
RECRUITING
Mumbai
Contact Information
Primary
Dr.Shraddha Patkar
drshraddhapatkar@gmail.com
+91 9820074818
Time Frame
Start Date: 2024-09-25
Estimated Completion Date: 2026-03
Participants
Target number of participants: 60
Sponsors
Leads: Tata Memorial Centre

This content was sourced from clinicaltrials.gov