NCT07337850 Prospective Evaluation of 68Ga-FAPI PET in Biliary Cancers
| NCT ID | NCT07337850 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tata Memorial Centre |
| Condition | Gall Bladder Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-09-25 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2024-09-25 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Dr.Shraddha Patkar
PRINCIPAL INVESTIGATOR
Tata Memorial Hospital
Frequently Asked Questions
Who can join the NCT07337850 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Gall Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07337850 currently recruiting?
Yes, NCT07337850 is actively recruiting participants. Contact the research team at drshraddhapatkar@gmail.com for enrollment information.
Where is the NCT07337850 trial being conducted?
This trial is being conducted at Mumbai, India.
Who is sponsoring the NCT07337850 clinical trial?
NCT07337850 is sponsored by Tata Memorial Centre. The principal investigator is Dr.Shraddha Patkar at Tata Memorial Hospital. The trial plans to enroll 60 participants.
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