[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623683":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":19,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":19,"studyType":59,"phases":60,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Princess Maxima Center for Pediatric Oncology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"anti-GD2-800CW","EXPERIMENTAL","Participants will receive a single dose of anti-GD2-800CW 96 hours prior to surgery.",[13],"Drug: anti-GD2-800CW",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Participants will receive a single dose of anti-GD2-800CW 96 hours prior to surgery. In phase Ib, using a 3+3 design, a dose escalation is performed to determine the RP2D.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Marieke Kietselaer","CONTACT","+31 88 972 7272","trialmanagement@prinsesmaximacentrum.nl",[27],{"facility":28,"status":29,"city":30,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Prinses Maxima Centrum","RECRUITING","Utrecht","Netherlands","NL",{"type":34,"coordinates":35},"Point",[36,37],5.12222,52.09083,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":24,"phoneExt":19,"email":42},"Lideke van der Steeg","a.f.w.vandersteeg@prinsesmaximacentrum.nl",{"type":44,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100623683","phase-1-an-imaging-study-of-anti-gd2-800cw-in-patients-with-neuroblastoma-100623683",false,"NCT07399821","An Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma","A Phase Ib\u002FII First-in-human Imaging Study of Anti-GD2-800CW in Patients With Neuroblastoma","GLOW-FISH","Inclusion Criteria:\n\n* Patients with the diagnosis of neuroblastoma as defined by histopathology (confirmed by the PMC Department of Pathology), who will be operated for NB as standard of care procedure\n* Patients older than 1 year of age and not older than 18 years.\n* Written informed consent from patients and\u002For from parents or legal guardians, according to local law and regulations\n\nExclusion Criteria:\n\n* Previous treatment with Dinutuximab-beta, either alone or in combination with chemotherapy\n* Pregnancy or positive pregnancy test (urine or serum) in females of childbearing potential. Pregnancy test must be performed within during the screening period and before the administration of the IMP.\n* Breast feeding.\n* Sexually active participants not willing to use highly effective contraceptive method (pearl index \\\u003C1) as defined in CTFG HMA 2020 (Appendix I) during trial participation and until 6 months after end of protocol therapy.\n* Patients that received prior treatment with chimeric antibodies.","ALL","1 Year","18 Years",{"count":57,"type":58},22,"ESTIMATED","INTERVENTIONAL",[61,62],"PHASE1","PHASE2","This is a non-randomized, open label phase Ib\u002FII dose-escalation and expansion study designed to define the recommended dose of anti-GD2-800CW in pediatric neuroblastoma patients. The aim of this imaging study is to determine a safe and effective dose of anti-GD2-800CW for intra-operative detection of neuroblastoma using NIR fluorescence.",[65],"Neuroblastoma",[65,67,68,69],"Fluorescence Guided Surgery","NIR fluorescence","pediatric oncology","2026-02-02",{"date":72,"type":73},"2026-02-10","ACTUAL",{"date":75,"type":73},"2025-11-05",{"date":77,"type":58},"2027-05-01",{"name":5,"class":6},1]