Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma

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.

Timeline

Start

—

Primary completion

—

Completion

—

Drugs

Indications