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NCT Number: NCT07337850

Prospective Evaluation of 68Ga-FAPI PET in Biliary Cancers

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.

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Key information

Conditions

Gall Bladder Cancer Adenocarcinoma Biliary Tract Diseases Biliary Tract Neoplasms Carcinoma Cholangiocarcinoma Cirrhosis, Familial, with Pulmonary Hypertension Digestive System Diseases Digestive System Neoplasms Gallbladder Diseases Gallbladder Neoplasms Intrahepatic Cholangiocarcinoma (Icc) Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Biliary tract cancers frequently present at an advanced stage and require accurate staging to guide treatment decisions such as surgery, systemic therapy, or palliative management. Although 18 F-FDG PET/CT is widely used in clinical practice, its diagnostic performance is limited in detecting small primary lesions, nodal metastasis, liver metastasis, and peritoneal carcinomatosis. Gallium-68 Fibroblast Activation Protein Inhibitor (FAPI) PET/CT is a novel imaging technology that targets cancer-associated fibroblasts, which are abundant in the desmoplastic stroma characteristic of biliary tract cancers. Early evidence suggests that FAPI PET/CT may provide improved lesion detectability and tumor-to-background contrast compared to FDG PET/CT.

This prospective observational study will evaluate the clinical utility of Ga-68 FAPI PET/CT for initial staging and suspected recurrence in patients with biliary tract cancers. Diagnostic performance metrics (sensitivity, specificity, PPV, NPV, and semi-quantitative PET parameters such as SUVmax and metabolic volume) will be assessed and compared with FDG PET/CT and/or follow-up imaging or histopathology as the gold standard. The study aims to determine the incremental diagnostic contribution of FAPI PET/CT and its potential impact on clinical decision-making.

Findings from this research may help define the role of FAPI PET/CT as a complementary or alternative imaging modality in staging and restaging of biliary tract cancers and may support future prospective multicenter trials.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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 Year

Study contacts

Contact information is provided by the study sponsor or research team.

Dr.Shraddha Patkar

CONTACT

[email protected]

+91 9820074818

Sponsors and collaborators

Lead sponsor

Tata Memorial Centre

Other

Registry information

Official study title

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

Acronym: FAPi-2

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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