[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100418147":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":42,"centralContacts":47,"locations":55,"responsibleParty":72,"collaborators":74,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":31,"enrollmentInfo":87,"targetDuration":31,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":58,"whyStopped":31,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-metastatic MIBC","ACTIVE_COMPARATOR","No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT\u002FMRI) and 18F-FDG-PET-CT's",[13],"Procedure: Standard of care",{"label":15,"type":16,"description":17,"interventionNames":18},"Oligo-metastatic MIBC on 18F-FDG-PET-CT","EXPERIMENTAL","No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT\u002FMRI) but presence of ≤ 3 metastasis on 1 or both 18F FDG PET-CT 's",[19],"Radiation: Metastasis directed therapy (MDT)",{"label":21,"type":16,"description":22,"interventionNames":23},"Poly-metastatic MIBC on 18F-FDG-PET-CT","No signs of extra-pelvic metastasis on conventional imaging (abdominopelvic and thoracic CT\u002FMRI) but presence of \\> 3 metastasis on 1 or both 18F FDG PET-CT 's",[24],"Drug: Immunotherapy",[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"RADIATION","Metastasis directed therapy (MDT)","Patient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Concurrently, the oligometastasis will be treated with stereotactic body radiotherapy or metastasectomy.",[15],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DRUG","Immunotherapy","Patient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Afterwards immunotherapy will be initiated and regular follow up will be performed.",[21],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":31},"PROCEDURE","Standard of care","Patient receives standard of care therapy with either radical cystectomy with pelvic lymph node dissection or trimodality therapy (consisting of a visible complete TURb and radio chemotherapy). Afterwards regular follow up is performed.",[9],[43],{"name":44,"affiliation":45,"role":46},"Valerie Fonteyne, MD; PhD","UZ Ghent","PRINCIPAL_INVESTIGATOR",[48,52],{"name":44,"role":49,"phone":50,"phoneExt":31,"email":51},"CONTACT","+3293323015","valerie.fonteyne@uzgent.be",{"name":53,"role":49,"phone":31,"phoneExt":31,"email":54},"Flor Verghote, MD","flor.verghote@uzgent.be",[56],{"facility":57,"status":58,"city":59,"state":31,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Ghent University Hospital","RECRUITING","Ghent","9000","Belgium","BE",{"type":64,"coordinates":65},"Point",[66,67],3.71667,51.05,{"lat":67,"lon":66},[70],{"name":71,"role":49,"phone":50,"phoneExt":31,"email":51},"Valerie Fonteyne",{"type":73,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[75],{"name":76,"class":6},"Kom Op Tegen Kanker","100418147","phase-2-evaluating-the-impact-of-18f-fdg-pet-ct-on-risk-stratification-and-treatment-adaptation-for-patients-with-muscle-invasive-bladder-cancer-100418147",false,"NCT04724928","Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer","Evaluating the Impact of 18F-FDG-PET-CT on Risk Stratification and Treatment Adaptation for Patients with Muscle Invasive Bladder Cancer (EFFORT-MIBC): a Phase II Prospective Trial","EFFORT-MIBC","Inclusion Criteria:\n\n* Histopathology-proven MIBC on TURb or ≥ T3 on conventional imaging treated with MIBC radical treatment\n* T1-4 N0-3 M0 MIBC on conventional imaging (thoracic CT and abdominopelvic CT\u002F MRI)\n* Age \\> 18 years\n* WHO 0-2\n* Willingness to undergo 18F-FDG-PET-CT\n* Willingness to undergo MDT or immunotherapy, in case of diagnosis of oligometastatic or polymetastatic disease on 18F-FDG-PET-CT, respectively\n* Willingness and ability to provide a signed informed consent according to ICH\u002FGCP and national\u002Flocal regulations\n\nExclusion Criteria:\n\n* Presence of distant metastasis on conventional imaging (thoracic CT and abdominopelvic CT\u002F MRI)\n* Refusal of or having contraindications to 18F-FDG-PET-CT\n* Refusal of MDT or immunotherapy\n* Prior radiotherapy unabling MDT\n* Contraindications to radiotherapy (including active inflammatory bowel disease)\n* Contraindications to immunotherapy\n* Other primary tumor diagnosed \\\u003C 5 years ago and for which treatment is still required, except for diagnosis of non-metastatic prostate cancer at time of diagnosis of MIBC or non-melanoma skin cancer.","ALL","18 Years",{"count":88,"type":89},156,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","Evaluate the impact of 18F-FDG-PET-CT on the staging of patients with muscle invasive bladder cancer. Based on the results of 2 18F-FDG-PET-CT's patients are stratified in non-metastatic, oligometastatic and polymetastatic bladder cancer patients and the treatment is adapted accordingly to improve overall survival.",[95],"Muscle-Invasive Bladder Carcinoma",[97,98,99,100,101,34],"18F-FDG-PET-CT","Staging","Distand metastasis","Oligometastatic disease","Metastasis directed therapy","2025-01-13",{"date":104,"type":105},"2025-01-15","ACTUAL",{"date":107,"type":105},"2021-04-29",{"date":109,"type":89},"2030-05",{"name":5,"class":6},1]