drugset / Trial / NCT01583842

124I-Metaiodobenzylguanidine (MIBG) PET/CT Diagnostic Imaging and Dosimetry for Patients With Neuroblastoma: A Pilot Study

NCT01583842 ↗

Non-randomizedSequentialOpen-labelDiagnostic

Summary

This is a pilot study with the primary purpose to describe organ dosimetry and acute toxicities using no carrier added and carrier added 124I-MIBG PET/CT in patients with neuroblastoma (NB). Eligible patients are 3 years of age and older with relapsed or refractory neuroblastoma who are currently enrolled on a treatment protocol with 131I-MIBG. After all eligibility criteria are met, patients will receive a diagnostic imaging dose of 124I-MIBG followed by sequential PET/CT dosimetry scans on Days 0, 1, 2 and 5. Subsequent, planned therapeutic administration of 131I-MIBG will occur between Days 7 to 21, as specified by the patient's therapeutic MIBG protocol. An optional single follow up 124I-MIBG PET-CT scan will be done to assess tumor sites 6 weeks after the patient has their MIBG therapy.

Timeline

Start
2013-04-09
Primary completion
2021-02-25
Completion
2021-02-25

Outcome

Outcome not reported

Stopped (Business): “Funding”

Drugs

EvaluationDrugModalityDoseRoute
Subject 124I-MIBG Diagnostic / imaging agent — —
Subject 124I-Metaiodobenzylguanidine Diagnostic / imaging agent — —

Indications