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: 0
• Participant gender: All

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.

Details

• Lead Sponsor: GE Healthcare
• Treatments: 3-Iodobenzylguanidine

Criteria

Inclusion Criteria:

• The patient has known or suspected neuroblastoma and is undergoing evaluation of disease status (for which a mIBG scintigraphic examination is clinically appropriate).

• The patient is able and willing to comply with study procedures and a signed and dated informed consent is obtained from the patient (or their legal guardian.

Exclusion Criteria:

• The patient uses medications that are known to interfere with [123I]mIBG uptake and these medications cannot be safely withheld for a least 24 hours before study procedures.