[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601486":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":29,"responsibleParty":71,"collaborators":18,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":18,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":97,"whyStopped":18,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Institut Curie","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"18F-MFBG PET\u002FCT imaging","EXPERIMENTAL","Participants will receive the 18F-MFBG tracer and undergo a PET\u002FCT imaging.",[13],"Procedure: 18F-MFBG PET\u002FCT imaging",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"PROCEDURE",[9],null,[20],{"name":21,"affiliation":5,"role":22},"Tissot Hubert, MD","PRINCIPAL_INVESTIGATOR",[24],{"name":25,"role":26,"phone":27,"phoneExt":18,"email":28},"Carole Cagnot","CONTACT","+33147111891","carole.cagnot@curie.fr",[30,46,57],{"facility":5,"status":18,"city":31,"state":18,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Paris","75005","France","FR",{"type":36,"coordinates":37},"Point",[38,39],2.3488,48.85341,{"lat":39,"lon":38},[42],{"name":43,"role":26,"phone":44,"phoneExt":18,"email":45},"Hubert Tissot, MD","+33156245990","hubert.tissot@curie.fr",{"facility":47,"status":18,"city":31,"state":18,"zip":48,"country":33,"countryCode":34,"cosmosGeoPoint":49,"geoPoint":51,"contacts":52},"Hôpital Armand Trousseau","75012",{"type":36,"coordinates":50},[38,39],{"lat":39,"lon":38},[53],{"name":54,"role":26,"phone":55,"phoneExt":18,"email":56},"Benedicte Jonca, MD","+33171738195","benedicte.jonca@aphp.fr",{"facility":58,"status":18,"city":59,"state":18,"zip":60,"country":33,"countryCode":34,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Gustave Roussy","Villejuif","94805",{"type":36,"coordinates":62},[63,64],2.35992,48.7939,{"lat":64,"lon":63},[67],{"name":68,"role":26,"phone":69,"phoneExt":18,"email":70},"Desiree Deandreis, MD","+33142116095","desiree.deandreis@gustaveroussy.fr",{"type":72,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100601486","phase-2-comparison-of-18f-labeled-analog-of-mibg-18f-mfbg-petct-and-123i-mibg-spect-in-pediatric-patients-with-neuroblastoma-100601486",false,"NCT07111117","Comparison of 18F Labeled Analog of MIBG (18F-MFBG) PET\u002FCT and 123I-MIBG SPECT in Pediatric Patients With Neuroblastoma.","Comparison of 18F Labeled Analog of MIBG (18F-MFBG) PET\u002FCT and 123I-MIBG SPECT in Pediatric Patients With Neuroblastoma","NEUROBLASTOTEP","Inclusion Criteria:\n\n1. Patients with histologically proven neuroblastoma.\n2. Relapsed or refractory neuroblastoma.\n3. 123I-MIBG avid neuroblastoma (positive 123I-MIBG scintigraphy = showing at least one neuroblastoma lesion (either primary or metastatic) with a significant avidity for 123I-MIBG), performed within 2 weeks to 2 days prior to 18F-MFBG PET\u002FCT.\n4. No specific treatment for neuroblastoma between 123I-MIBG scintigraphy and 18F-MFBG PET\u002FCT (PET\u002FCT shall not delay therapeutic management.)\n5. Age ≥ 365 days to \\\u003C 18 years old. For children under 13 months, day of birth should be collected.\n6. Weight ≥ 9 kg.\n7. Performance Status: Lansky or Karnofsky ≥ 60%.\n8. Signed written informed consent by the 2 holders of the parental authority or legal representative(s).\n9. Patients covered by a health insurance system.\n\nExclusion Criteria:\n\n1. Patient inability to comply with protocol requirements without general anesthesia.\n2. Pregnant or breastfeeding patient. If indicated, at the investigator's discretion, patients of childbearing potential should have urinary pregnancy test the day of the PET\u002FCT procedure, prior to the MFBG administration.\n3. Any treatment likely to interact with MIBG initiated\u002Fmodified between scintigraphy with MIBG and PET\u002FCT with MFBG.\n4. Patient with a parent or legal representative with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid informed consent","ALL","365 Days","17 Years",{"count":85,"type":86},30,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","The goals of the NEUROBLASTOTEP trial is to compare the diagnostics performance of a the 18F-metafluorobenzylguanidine (18F-MFBG) Positron Emission Tomography \u002F Computed Tomography scan (PET\u002FCT) compared to 123I-metaiodobenzylguanidine (123I-MIBG scintigraphy (current gold standard) for imaging in neuroblastoma.",[92],"Neuroblastoma",[92,94,95,96],"PET \u002F CT","Imaging","Radiotracer","NOT_YET_RECRUITING","2025-09-02",{"date":100,"type":101},"2025-09-03","ACTUAL",{"date":103,"type":86},"2026-03-01",{"date":105,"type":86},"2028-09",{"name":5,"class":6},3]