[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618917":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":23,"responsibleParty":43,"collaborators":7,"id":45,"slug":7,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":7,"studyType":58,"phases":7,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":25,"whyStopped":7,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Tata Memorial Centre","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DIAGNOSTIC_TEST","gallium-68-Fibroblast Activation Protein Inhibitor","Gallium-68 Fibroblast Activation Protein Inhibitor (Ga-68 FAPI) is a radiolabeled molecular imaging tracer used for PET\u002FCT 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\u002FCT 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\u002FCT in sensitivity and diagnostic accuracy for staging and recurrence assessment.",[14],{"name":15,"affiliation":16,"role":17},"Dr.Shraddha Patkar","Tata Memorial Hospital","PRINCIPAL_INVESTIGATOR",[19],{"name":15,"role":20,"phone":21,"phoneExt":7,"email":22},"CONTACT","+91 9820074818","drshraddhapatkar@gmail.com",[24],{"facility":15,"status":25,"city":26,"state":27,"zip":28,"country":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"RECRUITING","Mumbai","Maharashtra","400012","India",{"type":31,"coordinates":32},"Point",[33,34],72.88261,19.07283,{"lat":34,"lon":33},[37,39],{"name":38,"role":20,"phone":21,"phoneExt":7,"email":22},"Dr. Shraddha Patkar",{"name":40,"role":20,"phone":41,"phoneExt":7,"email":42},"Dr. Mahesh Goel","+91 9820504492","drmaheshgoel@gmail.com",{"type":44,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100618917",false,"NCT07337850","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","FAPi-2","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","ALL","18 Years","90 Years",{"count":56,"type":57},60,"ESTIMATED","OBSERVATIONAL","The goal of this prospective observational study is to evaluate whether Gallium-68 Fibroblast Activation Protein Inhibitor (FAPI) PET\u002FCT 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\u002FCT provide greater sensitivity, specificity and diagnostic accuracy for primary tumors, nodal disease, and metastatic lesions compared to standard FDG PET\u002FCT?\n\nDoes FAPI PET\u002FCT 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\u002FCT with FDG PET\u002FCT 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\u002FCT imaging (baseline and\u002For 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\u002FCT and\u002For follow-up imaging or histopathology as gold standard.",[61,62],"Gall Bladder Cancer","Intrahepatic Cholangiocarcinoma (Icc)",[64,65,66,67,68,69],"FAPI PET\u002FCT","Gallium-68 FAPI","Biliary Tract Cancer","Gallbladder Cancer","Cholangiocarcinoma","Intrahepatic Cholangiocarcinoma (iHCC)","2026-01-01",{"date":72,"type":73},"2026-01-13","ACTUAL",{"date":75,"type":73},"2024-09-25",{"date":77,"type":57},"2026-03",{"name":5,"class":6},1]