Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma
Status:
Approved for marketing
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
GE Healthcare has recently submitted a New Drug Application (NDA) for Iobenguane I 123
Injection ([123I]mIBG (AdreView)) as a diagnostic nuclear imaging agent for the detection of
primary or metastatic neuroblastoma and pheochromocytoma. The present protocol establishes an
Expanded Access program to provide AdreView to pediatric medical centers and hospitals that
treat neuroblastoma patients. AdreView will be provided for use in diagnostic assessment of
patients with known or suspected neuroblastoma for whom there is an appropriate clinical
indication for [123I]mIBG imaging.