[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481355":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":33,"interventions":40,"overallOfficials":26,"centralContacts":46,"locations":56,"responsibleParty":76,"collaborators":26,"id":78,"slug":26,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":26,"enrollmentInfo":87,"targetDuration":26,"studyType":90,"phases":91,"briefSummary":92,"conditions":93,"keywords":26,"overallStatus":59,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Wuerzburg University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":26},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"True positive rate per patient specimen","The probability of GET is given when immunhistochemistry test is positive.","24 months",{"measure":14,"description":15,"timeFrame":12},"True positive rate per patient","The probability of GET is given when 18F-PSMA-1007 PET\u002FCT is positive on a per patient basis.",{"measure":17,"description":18,"timeFrame":12},"Number of patients with identified tumor lesion sites","To compare the sites of disease identified on 18F-PSMA-1007 PET\u002FCT in patients with GET to images derived by conventional imaging to evaluate the sensitivity of 18F-PSMA-1007 PET\u002FCT.",[20,23],{"measure":21,"description":22,"timeFrame":12},"Ex-vivo PSMA expression","Expression of PSMA per specimen at immunhistochemistry.",{"measure":24,"description":25,"timeFrame":12},"PSMA uptake on 18F-PSMA-1007 PET","Quantified uptake of PSMA per tumor lesion basis.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE",[34],{"label":35,"type":36,"description":37,"interventionNames":38},"Gastroenterologic tumors histologically positive for PSMA","EXPERIMENTAL","Tumor biopsy at baseline to establish diagnosis and to identify PSMA expression in an ex-vivo setting. Patients with ex-vivo PSMA expression receive a multimodal imaging approach: This includes a PSMA-targeted PET\u002FCT (18F-PSMA) at baseline and conventional imaging.",[39],"Radiation: 18F-PSMA PET\u002FCT",[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":26},"RADIATION","18F-PSMA PET\u002FCT","Patients with metastasized gastroenterologic tumors, that exhibit histological PSMA expression, receive an additional 18F-PSMA PET\u002FCT to routine imaging.",[35],[47,52],{"name":48,"role":49,"phone":50,"phoneExt":26,"email":51},"Alexander M Weich, MD","CONTACT","+4993120140201","weich_A@ukw.de",{"name":53,"role":49,"phone":54,"phoneExt":26,"email":55},"Rudolf A Werner, MD","+4993120135001","werner_r4@ukw.de",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"University Hospital Wuerzburg","RECRUITING","Würzburg","Bavaria","97080","Germany","DE",{"type":66,"coordinates":67},"Point",[68,69],9.95121,49.79391,{"lat":69,"lon":68},[72,74],{"name":48,"role":49,"phone":50,"phoneExt":26,"email":73},"weich_a@ukw.de",{"name":53,"role":49,"phone":54,"phoneExt":26,"email":75},"werner_r1@ukw.de",{"type":77,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100481355",false,"NCT05547919","PSMA in Gastroenterologic Tumors (GIPSMA)","A Molecular Imaging-Derived Biomarker of PSMA Expression - Revealing Theranostic Potential in Gastroenterologic Tumors","GIPSMA","Inclusion Criteria:\n\n* Patients with newly diagnosed GET prior to initiation of guideline-compatible, anti-tumor therapy\n* Available tissue specimen to conduct PSMA expression profiling\n* Male\u002Ffemale, above 18 years old\n* Patients must provide written informed consent\n* Patients must be willing to comply with study procedures and available for follow-up examinations\n\nExclusion Criteria:\n\n* Curative setting\n* Not sufficient tumor tissue available\n* Male Patients: No prostate carcinoma\n* Other malignant neoplasms in patient's history\n* Pregnancy or Breastfeeding\n* Contraindications for PET\u002FCT","ALL","18 Years",{"count":88,"type":89},46,"ESTIMATED","INTERVENTIONAL",[28],"The theranostic principle is based on the use of radiolabeled compounds which can be applied for diagnostic molecular imaging and targeted delivery of radiation to the tumor. Gastroenterologic tumors (GET), including hepatocellular Carcinoma, Colorectal Carcinoma, Pancreatic Adenocarcinoma, Cholangiocellular Carcinoma, gastroenteropancreatic neuroendocrine neoplasms also express a phenotypic biomarker called prostate-specific membrane antigen (PSMA), thereby rendering it a potential diagnostic (through positron emission tomography (PET) scan imaging) and therapeutic target for radioligand therapy. Aim is to evaluate whether PSMA-directed in-vivo imaging can be also applied to GET patients to determine if i) biopsy-derived tissue of newly diagnosed patients exhibit a PSMA expression profile, ii) PSMA-PET shows upregulated PSMA expression in-vivo, iii) such a molecular imaging approach identifies more disease sites relative to conventional imaging, and iv) if the PSMA PET signal predicts further clinical course and outcome under guideline-compatible treatment.",[94],"Gastrointestinal Cancer","2025-09-23",{"date":97,"type":98},"2025-09-29","ACTUAL",{"date":100,"type":98},"2022-10-01",{"date":102,"type":89},"2026-10-01",{"name":5,"class":6},1]