[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100452500":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":71,"collaborators":26,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":26,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":26,"enrollmentInfo":83,"targetDuration":26,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":95,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Karolinska University Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Cancer patients","EXPERIMENTAL","* Adults with suspected cancer of either pancreas, bile ducts or stomach\n* Adults with primary and recurrent epithelial ovarian cancer (EOC)",[13,14],"Drug: 68Ga-FAPI-46","Device: PET\u002FCT",{"label":16,"type":17,"description":18,"interventionNames":19},"Non cancer patients","ACTIVE_COMPARATOR","Non cancer patients operated for non-malignant diseases in pancreas during the same period of time will be investigated with the same procedure.",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","68Ga-FAPI-46","* \\[68Ga\\] Ga-FAPI-46 Solution for Injection is manufactured at the Karolinska University Hospital Radiopharmacy facilities, for imaging studies with Positron Emission Tomography (PET).\n* It is a radiolabelled Fibroblast Activation Protein Inhibitor (FAPI) used for PET of a number of different cancer entities.\n* Depending on the labelling yield 50 - 370 megabecquerel (MBq) of \\[68Ga\\] Ga-FAPI-46 Solution for Injection will be administered intravenously 60 minutes prior to whole-body PET image acquisition.",[9,16],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DEVICE","PET\u002FCT","* Combined PET and computed tomography (CT) imaging with 68Ga-FAPI-46 will be performed using the same protocol on a \"Biograph 6\" PET\u002FCT scanner (Siemens, Erlangen, Germany) and \"General Electrics\" (GE) Discovery 710, Milwaukee, Wisconsin, USA at the Department of Nuclear Medicine, Karolinska Huddinge within 2 weeks before surgery.\n* PET\u002FCT imaging will be performed in dynamic mode at one bed position centered over the primary tumor for 45 minutes.\n* At 60 minutes post injection, a whole-body PET will be acquired.",[9,16],[33],{"name":34,"affiliation":35,"role":36},"Rimma Axelsson, Professor","Medical Radiation Physics and Nuclear Medicine, Karolinska University Hospital","PRINCIPAL_INVESTIGATOR",[38,42],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","+46 708 227 622","rimma.axelsson@ki.se",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Siri af Burén, MD","+46-739099570","siri.afburen@regionstockholm.se",[47],{"facility":48,"status":49,"city":50,"state":26,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Karolinska University Hospital Huddinge","RECRUITING","Stockholm","14186","Sweden","SE",{"type":55,"coordinates":56},"Point",[57,58],18.06871,59.32938,{"lat":58,"lon":57},[61,62,63,64,67,69],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},{"name":34,"role":36,"phone":26,"phoneExt":26,"email":26},{"name":65,"role":66,"phone":26,"phoneExt":26,"email":26},"Johannes Matthias Löhr, Professor","SUB_INVESTIGATOR",{"name":68,"role":66,"phone":26,"phoneExt":26,"email":26},"Magnus Nilsson, Professor",{"name":70,"role":66,"phone":26,"phoneExt":26,"email":26},"Ulrika Joneborg, MD PhD",{"type":36,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Rimma Axelsson","Professor","100452500","phase-1-pet-imaging-of-solid-tumors-by-a-novel-tracer-68ga-fapi-100452500",false,"NCT05172310","PET Imaging of Solid Tumors by a Novel Tracer, 68Ga-FAPI","PET Imaging of Tumors in Pancreas, Bile Ducts, Stomach and Ovaries by a Novel Tracer, 68Ga-FAPI-46 = Fibroblast Activation Protein Inhibitor","Inclusion Criteria:\n\n* Consecutive patients scheduled for surgical removal of either a pancreatic, biliary or gastric lesion.\n\n  \\- Consecutive patients scheduled for primary surgical removal of early stage epithelial ovarian cancer (EOC), interval debulking surgery of EOC or surgical removal or tissue biopsy of recurrent EOC\n* Signed informed consent.\n\nCommon Exclusion Criteria for all study populations:\n\n* Age ≤18 year\n* Pregnancy and lactation\n* Significantly reduced renal function\n* Allergy to iodinated contrast media\n* Subjects that for some reason are unable to exercise their own rights, such as cognitive function impairment.\n\nAdditional Exclusion Criteria for study populations with either pancreatic-, gastric or bile duct cancer:\n\n• Known metastatic disease","ALL","19 Years",{"count":84,"type":85},410,"ESTIMATED","INTERVENTIONAL",[88],"PHASE1","Cancers of the pancreas, bile ducts, stomach and ovaries are dismal diseases with most patients being diagnosed in advanced stages leading to a bad prognosis. These cancers can be difficult to diagnose and sometimes impossible to differentiate from underlying benign conditions. Establishing the correct diagnosis of primary cancer lesions and possible spread to other organs in time is pivotal for choosing the right therapy. Routinely applied staging procedures are however not always reliable. The main aim in this study is to evaluate the diagnostic accuracy of PET\u002FCT with a novel radiotracer, FAPI, in the primary diagnosis of cancers in the pancreas, stomach and bile ducts as well as in patients with primary and recurrent epithelial ovarian cancer (EOC).",[91,92,93,94],"Pancreatic Neoplasms","Stomach Neoplasms","Bile Duct Neoplasms","Epithelial Ovarian Cancer",[96,29,91,92,93,97,98,94],"68-Ga FAPI","Fibroblast activating protein inhibitor","FAPI","2021-12-13",{"date":101,"type":102},"2021-12-29","ACTUAL",{"date":104,"type":102},"2021-06-02",{"date":106,"type":85},"2029-03-31",{"name":5,"class":6},1]