[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598119":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":22,"studyPopulation":22,"armGroups":29,"interventions":36,"overallOfficials":42,"centralContacts":47,"locations":52,"responsibleParty":75,"collaborators":22,"id":78,"slug":22,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":22,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":22,"enrollmentInfo":86,"targetDuration":22,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":54,"whyStopped":22,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Sichuan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":22},[9,12],{"measure":10,"description":10,"timeFrame":11},"Incidence and severity of dose-limiting toxicities (DLTs)","From administration of IR-101 until 4 weeks after injection",{"measure":13,"description":13,"timeFrame":14},"Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0","From administration of IR-101 until 4 weeks after last dose of injection",[16,19],{"measure":17,"description":17,"timeFrame":18},"Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)","4 weeks after IR-101 administration",{"measure":20,"description":20,"timeFrame":21},"Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT\u002FCT dosimetry","About 21hours from time of IR-101 administration",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"NA","SEQUENTIAL","TREATMENT",{"masking":28,"maskingDescription":22,"whoMasked":22},"NONE",[30],{"label":31,"type":32,"description":33,"interventionNames":34},"Dose Escalation","EXPERIMENTAL","Study drug IR-101 Dose Escalation",[35],"Drug: IR-101",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":22},"DRUG","IR-101","IR-101 Dose Escalation",[31],[43],{"name":44,"affiliation":45,"role":46},"Rong Tian, MD","West China Hospital","PRINCIPAL_INVESTIGATOR",[48],{"name":44,"role":49,"phone":50,"phoneExt":22,"email":51},"CONTACT","18980601586","rongtiannuclear@126.com",[53,68],{"facility":45,"status":54,"city":55,"state":56,"zip":22,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Chengdu","Sichuang","China","CN",{"type":60,"coordinates":61},"Point",[62,63],104.06667,30.66667,{"lat":63,"lon":62},[66],{"name":67,"role":49,"phone":22,"phoneExt":22,"email":22},"Xiaoai Wu, Phd",{"facility":45,"status":54,"city":55,"state":22,"zip":22,"country":57,"countryCode":58,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},{"type":60,"coordinates":70},[62,63],{"lat":63,"lon":62},[73],{"name":74,"role":49,"phone":22,"phoneExt":22,"email":22},"Xiaoai Wu",{"type":46,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Rong Tian","Director","100598119",false,"NCT07067346","Safety & Efficacy of IR-101 in Relapsed\u002FRefractory Neuroblastoma","A Study to Evaluate Safety and Efficacy of Radiopharmaceutical IR-101 in Patients With Relapsed or Refractory Neuroblastoma","Inclusion Criteria:\n\n1. Relapsed or refractory high-risk neuroblastoma with MIBG avid lesions in accordance with the Revised International Neuroblastoma Response Criteria (INRC);\n2. All soft-tissue lesions detected on CT\u002FMRI must be MIBG-avid;\n3. Age ≥12 months;\n4. Lansky performance status ≥50%;\n5. Adequate organ function and hematologic parameters;\n\nExclusion Criteria:\n\n1. Antibody-based immunotherapy within 5 half-lives or 30 days (whichever is shorter), or not yet recovered from adverse reactions of prior biologic therapies；\n2. Treatment with \\[¹³¹I\\]MIBG or Lu-177 targeted radionuclide therapy \\\u003C3 months of last administration;\n3. Autologous transplant \\\u003C12 weeks, or Allogeneic transplant \\\u003C4 months (patients \\>4 months post-transplant must be free of active GVHD);\n4. Radiotherapy within 2 weeks prior to first dose of study drug (However, if the subjects undergone radiotherapy for the sole lesion have MIBG uptake after 2 weeks of radiotherapy completion, they will be eligible); or Extensive-field radiotherapy (e.g., Cranio-spinal cord, whole lung, whole abdomen, or \\>50% bone marrow) within 12 weeks prior to first dose of study drug;\n5. Renal Insufficiency;\n6. Active Infections;","ALL","12 Months",{"count":87,"type":88},10,"ESTIMATED","INTERVENTIONAL",[91],"EARLY_PHASE1","Radiopharmaceutical in Relapsed\u002FRefractory Neuroblastoma",[94],"Neuroblastoma",[96],"Radiopharmaceutical","2025-07-27",{"date":99,"type":100},"2025-07-29","ACTUAL",{"date":102,"type":100},"2025-07-18",{"date":104,"type":88},"2026-06-30",{"name":5,"class":6},2]