Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gall Bladder Cancer | — | UNRESOLVED | — |
| Intrahepatic Cholangiocarcinoma (Icc) | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gallium-68-Fibroblast Activation Protein Inhibitor | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic accuracy of Ga-68 FAPI PET/CT for detection of metastatic or recurrent disease (measured as sensitivity and specificity)
- timeFrame
- 1 Year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (40)
- BACKGROUNDPang Y, Zhao L, Luo Z, Hao B, Wu H, Lin Q, Sun L, Chen H. Comparison of 68Ga-FAPI and 18F-FDG Uptake in Gastric, Duodenal, and Colorectal Cancers. Radiology. 2021 Feb;298(2):393-402. doi: 10.1148/radiol.2020203275. Epub 2020 Dec 1. PMID 33258746
- BACKGROUNDChang MC, Chen JH, Liang JA, Huang WS, Cheng KY, Kao CH. PET or PET/CT for detection of peritoneal carcinomatosis: a meta-analysis. Clin Nucl Med. 2013 Aug;38(8):623-9. doi: 10.1097/RLU.0b013e318299609f. PMID 23797225
- BACKGROUNDKim SJ, Lee SW. Diagnostic accuracy of 18F-FDG PET/CT for detection of peritoneal carcinomatosis; a systematic review and meta-analysis. Br J Radiol. 2018 Jan;91(1081):20170519. doi: 10.1259/bjr.20170519. Epub 2017 Nov 21. PMID 29099613
- BACKGROUNDZhao L, Pang Y, Luo Z, Fu K, Yang T, Zhao L, Sun L, Wu H, Lin Q, Chen H. Role of [68Ga]Ga-DOTA-FAPI-04 PET/CT in the evaluation of peritoneal carcinomatosis and comparison with [18F]-FDG PET/CT. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1944-1955. doi: 10.1007/s00259-020-05146-6. Epub 2021 Jan 7. PMID 33415432
- BACKGROUNDLan L, Zhang S, Xu T, Liu H, Wang W, Feng Y, Wang L, Chen Y, Qiu L. Prospective Comparison of 68Ga-FAPI versus 18F-FDG PET/CT for Tumor Staging in Biliary Tract Cancers. Radiology. 2022 Sep;304(3):648-657. doi: 10.1148/radiol.213118. Epub 2022 May 17. PMID 35579524
- BACKGROUNDLoktev A, Lindner T, Burger EM, Altmann A, Giesel F, Kratochwil C, Debus J, Marme F, Jager D, Mier W, Haberkorn U. Development of Fibroblast Activation Protein-Targeted Radiotracers with Improved Tumor Retention. J Nucl Med. 2019 Oct;60(10):1421-1429. doi: 10.2967/jnumed.118.224469. Epub 2019 Mar 8. PMID 30850501
- BACKGROUNDLindner T, Loktev A, Altmann A, Giesel F, Kratochwil C, Debus J, Jager D, Mier W, Haberkorn U. Development of Quinoline-Based Theranostic Ligands for the Targeting of Fibroblast Activation Protein. J Nucl Med. 2018 Sep;59(9):1415-1422. doi: 10.2967/jnumed.118.210443. Epub 2018 Apr 6.