[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100334918":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":10,"locations":19,"responsibleParty":32,"collaborators":34,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":39,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":10,"studyType":51,"phases":10,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":60,"whyStopped":10,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},{"fullName":5,"class":6},"Odense University Hospital","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Suspected IBD",null,"A prospective study of 50 pediatric patients suspected of IBD. Participants will undergo routine diagnostic procedures for evaluation of pediatric IBD including blood samples, faecal samples, endoscopies (colonoscopy and gastroscopy with biopsy\u002Fhistology) and MRI of the abdomen. In addition, a PET scan will be performed in this protocol and combined with MRI. For accuracy measures, PET\u002FMRI scan will be compared to the combined findings of endoscopy, histology and severity of inflammation by clinical scoring systems (weighted Pediatric Crohn's Disease Activity Index (wPCDAI) for CD and Pediatric Ulcerative Colitis activity Index (PUCAI) for CU), faecal calprotectin and biochemistry.",{"label":13,"type":10,"description":14,"interventionNames":10},"Treatment response group","A pilot study of 10-15 patients previously diagnosed with CD who will undergo PET\u002FMRI scan as an investigational procedure before initiation of biological treatment with an anti-TNF-alpha antibody (infliximab, adalimumab) because of disease relapse or steroid dependent disease. Patients will be scheduled for a PET\u002FMRI again after one month. This study will evaluate if PET\u002FMRI can diagnose a flare in CD and if PET\u002FMRI is a reliable imaging tool to monitor intestinal inflammation. In this study the patient will act as his\u002Fher own control.",[16],{"name":17,"affiliation":5,"role":18},"Steffen Husby, Professor","PRINCIPAL_INVESTIGATOR",[20],{"facility":21,"status":10,"city":22,"state":10,"zip":23,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":10},"Steffen Husby","Odense","DK-5000","Denmark","DK",{"type":27,"coordinates":28},"Point",[29,30],10.38831,55.39594,{"lat":30,"lon":29},{"type":18,"investigatorFullName":21,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Professor, MD, DMSc",[35],{"name":36,"class":6},"University of Southern Denmark","100334918","the-role-of-petmri-in-the-diagnosis-and-treatment-of-children-and-adolescents-with-inflammatory-bowel-diseases-100334918",false,"NCT03640637","The Role of PET\u002FMRI in the Diagnosis and Treatment of Children and Adolescents With Inflammatory Bowel Diseases","Accuracy of PET\u002FMRI in Diagnosis and Treatment Evaluation of Children and Adolescents With Inflammatory Bowel Disease","PEDICAD","Inclusion Criteria:\n\n* Suspected of having IBD\n* Planned to undergo standard evaluation OR\n* Known Crohn's disease about to start anti-TNF therapy due to steroid dependency or disease relapse.\n\nExclusion Criteria:\n\n* Active or prior diagnosis of inflammatory disease other than IBD\n* Active or prior diagnosis of cancer\n* Type 1 diabetes\n* Not able to lie still for the MRI scan.","ALL","8 Years","25 Years",{"count":49,"type":50},75,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to test the utility of PET\u002FMRI in diagnosis and management of Inflammatory bowel disease (IBD) in children and adolescents, hereby\n\n* To test if PET\u002FMRI scan is an accurate method to diagnose and differentiate Crohn's disease and Ulcerous Colitis in children and adolescents suspected of IBD.\n* To evaluate whether PET\u002FMRI scan in children and adolescents with Crohn's disease is an accurate method to diagnose relapses and to monitor the effect of biological treatment with monoclonal antibodies directed towards Tumor Necrosis Factor-alpha.",[54,55,56],"Inflammatory Bowel Diseases","Crohn Disease","Ulcerative Colitis",[58,59],"Positron emission tomography","Magnetic resonance imaging","UNKNOWN","2020-04-24",{"date":63,"type":64},"2020-04-27","ACTUAL",{"date":66,"type":64},"2018-10-18",{"date":68,"type":50},"2021-08",{"name":5,"class":6},1]