[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597919":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":29,"locations":34,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":10,"maxAge":67,"enrollmentInfo":68,"targetDuration":71,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Nanjing First Hospital, Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pediatric Neuroblastoma Imaging Cohort",null,"This cohort includes pediatric patients (≤18 years) with suspected or confirmed neuroblastoma. Interventions include diagnostic imaging with ¹²³I-MIBG SPECT\u002FCT and SSTR PET\u002FCT for staging, therapy planning, and disease monitoring.",[13,14],"Diagnostic Test: ¹²³I-MIBG SPECT\u002FCT","Diagnostic Test: SSTR PET",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"DIAGNOSTIC_TEST","¹²³I-MIBG SPECT\u002FCT","Patients take Lugol's iodine 2 days and on the day of injection for thyroid blockade. ¹²³I-MIBG (3-5 MBq\u002Fkg; max 370 MBq) is given IV. Whole-body planar imaging is performed 24 h post-injection, then focused SPECT\u002FCT of any suspicious areas with low-dose CT; children are sedated only if motion control is required.",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"SSTR PET","Patients receive an intravenous bolus of 68Ga-DOTA-TATE (1.8-2.2 MBq\u002Fkg, max 200 MBq). After a 45-60 min uptake phase, a low-dose whole-body PET\u002FCT or PET\u002FMRI (skull base-mid-thigh) is acquired for \\~20 min; MRI or CT provides attenuation correction. Sedation used when required.",[9],[26],{"name":27,"affiliation":5,"role":28},"Guoqiang Shao, Dr","STUDY_CHAIR",[30],{"name":27,"role":31,"phone":32,"phoneExt":10,"email":33},"CONTACT","+86 153 6615 5689","guoqiangshao@163.com",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Nanjing First Hospital","RECRUITING","Nanjing","Jiangsu","210000","China","CN",{"type":44,"coordinates":45},"Point",[46,47],118.77778,32.06167,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":52,"phoneExt":10,"email":53},"Ying Zhang","+86 25 5227 1064","njsdyyykyll@163.com",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[57],{"name":58,"class":6},"Jiangsu Province Hospital of Traditional Chinese Medicine","100597919","clinical-application-study-of-123imetaiodobenzylguanidine-and-somatostatin-receptor-targeted-imaging-in-the-diagnosis-and-staging-of-neuroblastoma-100597919",false,"NCT07064746","Clinical Application Study of [123I]Metaiodobenzylguanidine and Somatostatin Receptor-Targeted Imaging in the Diagnosis and Staging of Neuroblastoma","MIBG & SSTR NB","Inclusion Criteria:\n\n1. Ages 0-18 years, any sex\n2. Histologically confirmed or clinically highly suspected neuroblastoma with planned imaging assessment\n3. At least one measurable lesion on conventional imaging such as CT or MRI\n4. ECOG performance status 0-2 and an expected survival of ≥3 months\n5. Hematologic, hepatic, and renal function meeting the following criteria: Hb ≥ 90 g\u002FL, ANC ≥ 1.5 × 10⁹\u002FL, platelets ≥ 100 × 10⁹\u002FL, ALT\u002FAST ≤ 2.5 × ULN, Cr ≤ 1.5 × ULN\n6. Informed consent signed by the subject or legal guardian\n\nExclusion Criteria:\n\n1. Known history of severe allergy to the radioactive isotope or molecular probe components to be used;\n2. Pregnancy or lactation;\n3. Receipt of high-dose chemotherapy\u002Fradiotherapy, radionuclide therapy, or participation in other interventional clinical trials within the past 4 weeks;\n4. Severe or uncontrolled cardiac, pulmonary, hepatic, or renal insufficiency, or active severe infection;\n5. Bone marrow suppression not yet recovered (Hb \\\u003C 90 g\u002FL, ANC \\\u003C 1.5 × 10⁹\u002FL, platelets \\\u003C 100 × 10⁹\u002FL);\n6. Inability to complete imaging examinations such as PET\u002FCT (e.g., severe claustrophobia, inability to lie supine for ≥ 30 min);\n7. Any other situation deemed inappropriate for enrollment by the investigator.","ALL","18 Years",{"count":69,"type":70},150,"ESTIMATED","6 Months","OBSERVATIONAL","The goal of this prospective observational study is to evaluate the diagnostic performance of ¹²³I-MIBG SPECT\u002FCT and SSTR PET in Chinese children with suspected or confirmed neuroblastoma (NB). The main questions it aims to answer are:\n\n* What are the sensitivity and specificity of each modality-alone and combined-for initial staging and for detecting relapse or metastasis?\n* Can SSTR-targeted PET reliably identify MIBG-negative NB lesions and help select candidates for peptide-receptor radionuclide therapy (PRRT)?\n\nPediatric patients (≤18 years) undergoing routine evaluation for NB will receive both imaging studies; results will be correlated with histopathology, clinical course, and 24-month follow-up.",[75],"Neuroblastoma (NB)",[77,78,79,80],"neuroblastoma","SSTR","MIBG","PET","2025-07-17",{"date":83,"type":84},"2025-07-21","ACTUAL",{"date":86,"type":84},"2022-07-10",{"date":88,"type":70},"2027-07-10",{"name":5,"class":6},1]