[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607972":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":21,"responsibleParty":41,"collaborators":10,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":10,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":10,"enrollmentInfo":52,"targetDuration":51,"studyType":55,"phases":10,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":24,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Nanjing First Hospital, Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Neuroblastoma and PPGL Patients Undergoing SSTR\u002FNET Imaging",null,"This cohort includes patients with suspected or confirmed neuroblastoma (NB) or pheochromocytoma\u002Fparaganglioma (PPGL) undergoing somatostatin receptor (SSTR) and\u002For norepinephrine transporter (NET)-targeted molecular imaging for diagnostic evaluation and staging. Interventions of interest are diagnostic radiopharmaceutical administrations followed by imaging-there is no therapeutic intent. Participants may receive one or more NET tracers, including 18F-MFBG, 123I-MIBG, 131I-MIBG (legacy diagnostic where appropriate), 18F-LMI1195, and\u002For SSTR tracers, including 68Ga-DOTATATE, 68Ga-DOTATOC, 68Ga-DOTANOC, 64Cu-DOTATATE, 18F-SiTATE, 18F-AlF-NOTA-octreotide, depending on clinical indication and site availability. Imaging is performed on PET\u002FCT or PET\u002FMRI for PET tracers and SPECT\u002FCT for SPECT tracers using harmonized acquisition and reconstruction parameters. When clinically justified",[13],{"name":14,"affiliation":5,"role":15},"Guoqiang Shao, Dr","STUDY_DIRECTOR",[17],{"name":14,"role":18,"phone":19,"phoneExt":10,"email":20},"CONTACT","+86 153 6615 5689","guoqiangshao@163.com",[22],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Nanjing First Hospital","RECRUITING","Nanjing","Jiangsu","210000","China","CN",{"type":31,"coordinates":32},"Point",[33,34],118.77778,32.06167,{"lat":34,"lon":33},[37],{"name":38,"role":18,"phone":39,"phoneExt":10,"email":40},"Ying Zhang","+86 25 5227 1064","njsdyyykyll@163.com",{"type":42,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100607972","clinical-application-of-somatostatin-receptor-and-norepinephrine-transporter-targeted-imaging-for-diagnosis-and-staging-of-neuroblastoma-and-pheochromocytomaparaganglioma-100607972",false,"NCT07195500","Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for Diagnosis and Staging of Neuroblastoma and Pheochromocytoma\u002FParaganglioma","the Clinical Application of Somatostatin Receptor and Norepinephrine Transporter Targeted Imaging for the Diagnosis and Staging of Neuroblastoma and Pheochromocytoma\u002FParaganglioma","Inclusion Criteria:\n\n* Age: ≥6 months (pediatric and adult).\n* Suspected or confirmed diagnosis of neuroblastoma (NB) or pheochromocytoma\u002Fparaganglioma (PPGL).\n* Clinical indication for SSTR and\u002For NET-targeted molecular imaging for initial staging, restaging, suspected recurrence, response assessment, or treatment planning.\n* Ability to undergo PET\u002FCT or PET\u002FMRI and\u002For SPECT\u002FCT per protocol; for the PET\u002FMRI subset, no MRI contraindications.\n* Provision of written informed consent\u002Fassent per local regulations.\n* Women of childbearing potential: negative pregnancy test within 72 hours prior to tracer administration and agreement to use effective contraception during the imaging window.\n* For the multi-tracer subset (if applicable): willingness to undergo two imaging studies within a predefined window (e.g., ≤28 days) without intervening antitumor therapy.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding; breastfeeding participants unwilling to follow tracer-specific lactation interruption guidance per institutional policy.\n* Any condition that, in the investigator's judgment, precludes safe imaging or protocol compliance (e.g., uncontrolled cardiorespiratory disease, severe claustrophobia not amenable to sedation\u002Fanxiolysis).\n* Known hypersensitivity to study radiopharmaceuticals or their excipients.\n* Use of interfering medications without feasible washout:\n\nNET imaging: drugs that affect catecholamine transport\u002Fstorage (e.g., labetalol, tricyclic antidepressants, certain sympathomimetics) per site SOPs.\n\nSSTR imaging: long-acting somatostatin analogues within \\~3-4 weeks or short-acting within \\~24-48 hours, unless clinically unavoidable.\n\n* Prior therapeutic or high-dose 131I-MIBG within a period that would confound diagnostic imaging or dosimetry (e.g., within 6 months), at the investigator's discretion.\n* Contraindications to required modality-specific procedures (e.g., MRI-incompatible implants for PET\u002FMRI; iodinated\u002Fgadolinium contrast contraindication only if contrast is mandated and no alternative pathway is acceptable).\n* Inability to lie still for the required acquisition time and sedation not feasible per institutional policy.\n* Concurrent participation in an interventional study or receipt of anticancer therapy that would confound imaging interpretation within the imaging window; for multi-tracer comparisons, any interval systemic therapy between scans.","ALL","6 Months",{"count":53,"type":54},30,"ESTIMATED","OBSERVATIONAL","The goal of this clinical trial is to evaluate the diagnostic efficacy of somatostatin receptor and norepinephrine transporter targeted imaging (including 18F-MFBG, 123I-MIBG, 131I-MIBG, 68Ga-DOTA-NOC, 68Ga-DOTA-TATE, 68Ga-DOTA-TOC, and other radiolabeled somatostatin analogues) in the diagnosis and staging of neuroblastoma and pheochromocytoma\u002Fparaganglioma patients aged 1-70 years. The main questions it aims to answer are:\n\nCan molecular targeted imaging using various norepinephrine transporter tracers (18F-MFBG, 123I\u002F131I-MIBG) and somatostatin receptor tracers (68Ga-DOTA-peptides series) accurately detect primary tumors and metastatic lesions in neuroblastoma\u002Fpheochromocytoma patients? What is the comparative diagnostic performance (sensitivity, specificity, accuracy) of different molecular imaging techniques compared to histopathological diagnosis as the gold standard? Researchers will compare the imaging findings from multiple tracer types with surgical pathology results to assess diagnostic accuracy and clinical staging precision.\n\nParticipants will:\n\n* Undergo screening assessments including medical history, physical examination, and laboratory tests\n* Receive intravenous injection of selected tracers (18F-MFBG, 68Ga-DOTA-NOC\u002FTATE, or other appropriate agents) at standardized doses followed by PET-CT\u002FMRI imaging at optimal time points\n* Undergo histopathological examination within 2 months post-imaging\n* Complete safety follow-up for 6 months to monitor for any adverse reactions to the imaging agents",[58,59,60],"Neuroblastoma","Pheochromocytoma","Paraganglioma",[62,63,64,65,66,67],"neuroblastoma","PET","pheochromocytoma","paraganglioma","somatostatin receptor","norepinephrine transporter","2025-09-19",{"date":70,"type":71},"2025-09-26","ACTUAL",{"date":73,"type":71},"2024-12-25",{"date":75,"type":54},"2028-06-30",{"name":5,"class":6},1]