[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416388":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":59,"collaborators":27,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":27,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":27,"enrollmentInfo":70,"targetDuration":27,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":40,"whyStopped":27,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University of Liege","OTHER",[8,13,17],{"label":9,"type":6,"description":10,"interventionNames":11},"Humoral Arm","The renal biopsy shows signs of humoral rejection: the patient is excluded from the study and is treated \"as usual\" on the basis of the histological results.",[12],"Diagnostic Test: 18FDG PET \u002F CT",{"label":14,"type":6,"description":15,"interventionNames":16},"\"Highly Metabolic patients\"","The renal biopsy does not show signs of humoral rejection but the 18FDG PET \u002F CT shows a high metabolic activity of the graft (\\> 2.4): the patient is treated \"as usual\" on the basis of histological findings.",[12],{"label":18,"type":6,"description":19,"interventionNames":20},"\" Low metabolic patients\"","The renal biopsy does not show signs of humoral rejection and the 18FDG PET \u002F CT shows a weak metabolic activity of the graft (\\\u003C2.4): the immunosuppressive treatment is gradually weaned off corticosteroids.",[12],[22],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DIAGNOSTIC_TEST","18FDG PET \u002F CT","The PET\u002FCT procedure was performed using cross-calibrated Philips Gemini TF Big Bore or TF 16 PET\u002FCT systems (Philips Medical Systems, Cleveland, OH) at 201 18 minutes following intravenous injection of a mean dose of 3.2 0.2 MBq\u002Fkg of body weight of 18 F-FDG. A low-dose helical CT (5-mm slice thickness, 120-kV tube voltage, and 40-mAs tube current-time product) centered to the renal transplant was performed, followed by PET scanning with two bed positions, each lasting 240 seconds. Images were reconstructed using iterative list mode time-of-flight algorithms. Corrections for attenuation, dead time and random and scatter events will be applied.",[18,14,9],null,[29],{"name":30,"affiliation":5,"role":31},"Francois Jouret","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":27,"email":37},"Antoine Bouquegneau","CONTACT","+32473353321","antoine.bouquegneau@gmail.com",[39],{"facility":34,"status":40,"city":41,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Liège","4000","Belgium","BE",{"type":46,"coordinates":47},"Point",[48,49],5.56749,50.63373,{"lat":49,"lon":48},[52,54,57],{"name":53,"role":35,"phone":36,"phoneExt":27,"email":37},"Antoine Bouquegneau, MD",{"name":55,"role":35,"phone":27,"phoneExt":27,"email":56},"Francois Jouret, PhD","francois.jouret@chuliege.be",{"name":58,"role":31,"phone":27,"phoneExt":27,"email":27},"Laurent Weekers, MD,",{"type":31,"investigatorFullName":34,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Principal Investigator","100416388","added-value-of-18-fdg-pet-scanner-in-diagnosis-and-management-of-subclinical-rejection-in-kidney-transplant-patients-100416388",false,"NCT04702022","Added Value of 18 FDG Pet-scanner in Diagnosis and Management of Subclinical Rejection in Kidney Transplant Patients","Non-invasive Diagnosis and Management of Subclinical Rejection in Kidney Transplant Patients Using 18F-fluorodeoxy Glucose Positron Emission Tomography (18FDG-PET\u002FCT)","Inclusion Criteria:\n\n* Kidney recipients aged over 18 and of all sexes\n\nExclusion Criteria:\n\n* Pregnant patients\n* Polyomavirus nephropathy\n* Highly sensitised patients (historical or at 3 months Donor specific antibodies)\n* No corticosteroids withdrawal allowed (second kidney transplantation or primary disease)","ALL","18 Years",{"count":71,"type":72},50,"ESTIMATED","INTERVENTIONAL",[75],"NA","The renal biopsy (RB) represents the gold-standard for the diagnosis of acute renal transplant rejection (AR), and allows early verification of a so-called \"subclinical\" rejection, ie without any clinical or biological abnormality detectable in a stable kidney transplant patient. The RB also makes it possible to certify a strictly normal renal histology and thus to motivate the withdrawal of corticosteroid therapy. It is this 3-month post-transplant protocol RB protocol that has been effective since 2007 at the CHU Liège.\n\nHowever, RB is an invasive procedure, contraindicated in patients taking anticoagulants, and carrying a significant risk of complications. The potential complications associated with RB motivate the identification and validation of other diagnostic means. In the present project, the investigators propose to study the relevance of positron emission tomography (PET), coupled with conventional tomography (CT), after intravenous injection of 18-fluoro-deoxy-glucose (18FDG) in the overall protocol of the renal transplant patient at 3 months post-transplant to:\n\n(i) allow protocol renal biopsy only in patients with suspicion of an acute rejection (ii) be a decision maker for withdrawal from corticosteroids in the absence of rejection\n\nIn practice, the investigators suggest performing 18FDG PET \u002F CT imaging on the day of the surveillance biopsy, which is systematically performed in all kidney transplant patients at University Hospital of Liège 3 months after transplant. The investigators are considering 3 scenarios:\n\n* Scenario 1. The renal biopsy shows signs of humoral rejection: the patient is excluded from the study and is treated \"as usual\" on the basis of the histological results.\n* Scenario 2. The renal biopsy does not show signs of humoral rejection but the 18FDG PET \u002F CT shows a high metabolic activity of the graft (\\> 2.4): the patient is treated \"as usual\" on the basis of histological findings.\n* Scenario 3. The renal biopsy does not show signs of humoral rejection and the 18FDG PET \u002F CT shows a weak metabolic activity of the graft (\\\u003C2.4): the immunosuppressive treatment is gradually weaned off corticosteroids.\n\nThis clinical research project is interested in a major health problem in the follow-up of renal transplant patients, and could make it possible to improve the management of a subclinical rejection of the renal transplant and to increase the withdrawal of corticosteroids including side effects are well known.",[78,79],"Kidney Transplant Rejection","Kidney Transplant; Complications",[81,82,83],"PET\u002FCT imaging","Corticoids withdrawal","SubClinical Rejection","2025-04-06",{"date":86,"type":87},"2025-04-09","ACTUAL",{"date":89,"type":87},"2021-01-04",{"date":91,"type":72},"2027-01-01",{"name":5,"class":6},1]