Gall Bladder CancerFAPi-2NCT07337850
Prospective Evaluation of 68Ga-FAPI PET in Biliary Cancers
An observational study of Gall Bladder Cancer and Intrahepatic Cholangiocarcinoma (Icc), run by Tata Memorial Centre at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gall Bladder Cancer, Intrahepatic Cholangiocarcinoma (Icc)
- What is being tested?
- gallium-68-Fibroblast Activation Protein Inhibitor
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 25 Sep 2024to Mar 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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)
Who cannot join
- Informed consent withdrawal
- Concurrent Malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Dr.Shraddha Patkar
Mumbai, Maharashtra, 400012
Dr. Shraddha Patkar, +91 9820074818, drshraddhapatkar@gmail.com
Dr. Mahesh Goel, +91 9820504492, drmaheshgoel@gmail.com
About this study
Official title: FAP 2: Utility of Gallium-68-Fibroblast Activation Protein Inhibitor (FAPI) PET in Biliary Tract Cancers: A Prospective Study
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:
Read more
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.
Read the detailed description
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.
- Being tested
- gallium-68-Fibroblast Activation Protein Inhibitor
- Keywords
- FAPI PET/CT, Gallium-68 FAPI, Biliary Tract Cancer, Gallbladder Cancer, Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma (iHCC)
- Medical subject headings
- Gallbladder Neoplasms, Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gallium-68-Fibroblast Activation Protein InhibitorDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of Ga-68 FAPI PET/CT for detection of metastatic or recurrent disease (measured as sensitivity and specificity)
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start25 Sep 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Gall Bladder CancerStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr.Shraddha Patkar, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337850
- Sponsor's protocol ID
- Study no:- 4455
- Other IDs
- 6429
- Acronym
- FAPi-2
- Status last verified
- Jan 2026
- First submitted
- 1 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pang 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.
PubMed 33258746Chang 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.
PubMed 23797225Kim 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.
PubMed 29099613Zhao 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.
PubMed 33415432Lan 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.
PubMed 35579524Loktev 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.
PubMed 30850501Lindner 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.
PubMed 29626119Goere D, Wagholikar GD, Pessaux P, Carrere N, Sibert A, Vilgrain V, Sauvanet A, Belghiti J. Utility of staging laparoscopy in subsets of biliary cancers : laparoscopy is a powerful diagnostic tool in patients with intrahepatic and gallbladder carcinoma. Surg Endosc. 2006 May;20(5):721-5. doi: 10.1007/s00464-005-0583-x. Epub 2006 Feb 27.
PubMed 16508808Agarwal AK, Kalayarasan R, Javed A, Gupta N, Nag HH. The role of staging laparoscopy in primary gall bladder cancer--an analysis of 409 patients: a prospective study to evaluate the role of staging laparoscopy in the management of gallbladder cancer. Ann Surg. 2013 Aug;258(2):318-23. doi: 10.1097/SLA.0b013e318271497e.
PubMed 23059504Petrowsky H, Wildbrett P, Husarik DB, Hany TF, Tam S, Jochum W, Clavien PA. Impact of integrated positron emission tomography and computed tomography on staging and management of gallbladder cancer and cholangiocarcinoma. J Hepatol. 2006 Jul;45(1):43-50. doi: 10.1016/j.jhep.2006.03.009. Epub 2006 Apr 19.
PubMed 16690156Lamarca A, Barriuso J, Chander A, McNamara MG, Hubner RA, OReilly D, Manoharan P, Valle JW. 18F-fluorodeoxyglucose positron emission tomography (18FDG-PET) for patients with biliary tract cancer: Systematic review and meta-analysis. J Hepatol. 2019 Jul;71(1):115-129. doi: 10.1016/j.jhep.2019.01.038. Epub 2019 Feb 21.
PubMed 30797051Rodriguez-Fernandez A, Gomez-Rio M, Medina-Benitez A, Moral JV, Ramos-Font C, Ramia-Angel JM, Llamas-Elvira JM, Ferron-Orihuela JA, Lardelli-Claret P. Application of modern imaging methods in diagnosis of gallbladder cancer. J Surg Oncol. 2006 Jun 15;93(8):650-64. doi: 10.1002/jso.20533.
PubMed 16724342Bedmutha AS, Agrawal A, Rangarajan V, Goel M, Patkar S, Puranik AD, Ramadwar M, Purandare NC, Shah S, Choudhury S. Diagnostic performance of F-18 FDG PET/CT in recurrent adenocarcinoma gallbladder and its impact on post-recurrence survival. Jpn J Radiol. 2023 Feb;41(2):201-208. doi: 10.1007/s11604-022-01340-8. Epub 2022 Sep 19.
PubMed 36121626Goel M, Tamhankar A, Rangarajan V, Patkar S, Ramadwar M, Shrikhande SV. Role of PET CT scan in redefining treatment of incidental gall bladder carcinoma. J Surg Oncol. 2016 May;113(6):652-8. doi: 10.1002/jso.24198. Epub 2016 Feb 5.
PubMed 26847023Kang Y, Lee JM, Kim SH, Han JK, Choi BI. Intrahepatic mass-forming cholangiocarcinoma: enhancement patterns on gadoxetic acid-enhanced MR images. Radiology. 2012 Sep;264(3):751-60. doi: 10.1148/radiol.12112308. Epub 2012 Jul 12.
PubMed 22798225