Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:22 AM
Study NCT ID:
NCT07337850
Status:
RECRUITING
Last Update Posted:
2026-01-13
First Post:
2026-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of 68Ga-FAPI PET in Biliary Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005706', 'term': 'Gallbladder Neoplasms'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'C562580', 'term': 'Cirrhosis, Familial, with Pulmonary Hypertension'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-01', 'studyFirstSubmitDate': '2026-01-01', 'studyFirstSubmitQcDate': '2026-01-01', 'lastUpdatePostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of Ga-68 FAPI PET/CT for detection of metastatic or recurrent disease (measured as sensitivity and specificity)', 'timeFrame': '1 Year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FAPI PET/CT', 'Gallium-68 FAPI', 'Biliary Tract Cancer', 'Gallbladder Cancer', 'Cholangiocarcinoma', 'Intrahepatic Cholangiocarcinoma (iHCC)'], 'conditions': ['Gall Bladder Cancer', 'Intrahepatic Cholangiocarcinoma (Icc)']}, 'referencesModule': {'references': [{'pmid': '33258746', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23797225', 'type': 'BACKGROUND', 'citation': 'Chang 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': '29099613', 'type': 'BACKGROUND', 'citation': 'Kim 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': '33415432', 'type': 'BACKGROUND', 'citation': 'Zhao 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': '35579524', 'type': 'BACKGROUND', 'citation': 'Lan 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': '30850501', 'type': 'BACKGROUND', 'citation': 'Loktev 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': '29626119', 'type': 'BACKGROUND', 'citation': 'Lindner T, Loktev A, Altmann A, Giesel F, Kratochwil C, Debus J, Jager D, Mier W, Haberkorn U. 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Epub 2019 Feb 21.'}, {'pmid': '16724342', 'type': 'BACKGROUND', 'citation': 'Rodriguez-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.'}, {'pmid': '36121626', 'type': 'BACKGROUND', 'citation': 'Bedmutha 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.'}, {'pmid': '26847023', 'type': 'BACKGROUND', 'citation': 'Goel M, Tamhankar A, Rangarajan V, Patkar S, Ramadwar M, Shrikhande SV. Role of PET CT scan in redefining treatment of incidental gall bladder carcinoma. 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Epub 2021 Oct 15.'}, {'pmid': '36581374', 'type': 'BACKGROUND', 'citation': 'Hirmas N, Hamacher R, Sraieb M, Ingenwerth M, Kessler L, Pabst KM, Barbato F, Lueckerath K, Kasper S, Nader M, Schildhaus HU, Kesch C, von Tresckow B, Hanoun C, Hautzel H, Aigner C, Glas M, Stuschke M, Kummel S, Harter P, Lugnier C, Uhl W, Niedergethmann M, Hadaschik B, Grunwald V, Siveke JT, Herrmann K, Fendler WP. Fibroblast-Activation Protein PET and Histopathology in a Single-Center Database of 324 Patients and 21 Tumor Entities. J Nucl Med. 2023 May;64(5):711-716. doi: 10.2967/jnumed.122.264689. Epub 2022 Dec 29.'}, {'pmid': '34740953', 'type': 'BACKGROUND', 'citation': 'Mona CE, Benz MR, Hikmat F, Grogan TR, Lueckerath K, Razmaria A, Riahi R, Slavik R, Girgis MD, Carlucci G, Kelly KA, French SW, Czernin J, Dawson DW, Calais J. 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Comparison on the efficacy and prognosis of different strategies for intrahepatic recurrent hepatocellular carcinoma: A systematic review and Bayesian network meta-analysis. Int J Surg. 2020 Nov;83:196-204. doi: 10.1016/j.ijsu.2020.09.031. Epub 2020 Sep 25.'}, {'pmid': '33538338', 'type': 'BACKGROUND', 'citation': 'Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe main question(s) this study aims to answer are:\n\nCan FAPI PET/CT provide greater sensitivity, specificity and diagnostic accuracy for primary tumors, nodal disease, and metastatic lesions compared to standard FDG PET/CT?\n\nDoes FAPI PET/CT offer additional diagnostic yield that may affect clinical decision-making and staging, potentially reducing need for invasive staging procedures?\n\nResearchers 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.\n\nParticipants will:\n\nProvide written informed consent.\n\nUndergo FAPI PET/CT imaging (baseline and/or at suspected biochemical or radiologic recurrence).\n\nHave quantitative imaging parameters evaluated (SUVmax, tumor-to-liver ratios, metabolic volume).\n\nMay undergo comparison with FDG PET/CT and/or follow-up imaging or histopathology as gold standard.', 'detailedDescription': '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.\n\nThis 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.\n\nFindings 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected biliary tract cancers- iHCC and GBC\n* Male and females ≥ 18 years;\n* Upfront advanced (suspected T3 ,T4, N1, vascular involvement)\n* iGBC (residual, N1)\n* Suspected post-treatment recurrence (biochemical or radiological)\n\nExclusion Criteria:\n\n* Informed consent withdrawal\n* Concurrent Malignancy'}, 'identificationModule': {'nctId': 'NCT07337850', 'acronym': 'FAPi-2', 'briefTitle': 'Prospective Evaluation of 68Ga-FAPI PET in Biliary Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Tata Memorial Centre'}, 'officialTitle': 'FAP 2: Utility of Gallium-68-Fibroblast Activation Protein Inhibitor (FAPI) PET in Biliary Tract Cancers: A Prospective Study', 'orgStudyIdInfo': {'id': 'Study no:- 4455'}, 'secondaryIdInfos': [{'id': '6429', 'type': 'OTHER_GRANT', 'domain': 'Tata Memorial Hospital'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gallium-68-Fibroblast Activation Protein Inhibitor', 'type': 'DIAGNOSTIC_TEST', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '400012', 'city': 'Mumbai', 'state': 'Maharashtra', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr. Shraddha Patkar', 'role': 'CONTACT', 'email': 'drshraddhapatkar@gmail.com', 'phone': '+91 9820074818'}, {'name': 'Dr. Mahesh Goel', 'role': 'CONTACT', 'email': 'drmaheshgoel@gmail.com', 'phone': '+91 9820504492'}], 'facility': 'Dr.Shraddha Patkar', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}], 'centralContacts': [{'name': 'Dr.Shraddha Patkar', 'role': 'CONTACT', 'email': 'drshraddhapatkar@gmail.com', 'phone': '+91 9820074818'}], 'overallOfficials': [{'name': 'Dr.Shraddha Patkar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tata Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tata Memorial Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}