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

APPROVED_FOR_MARKETING

Conditions studied: Neuroblastoma

In brief

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.

Key facts

Study ID

NCT00730444

Run by

GE Healthcare

Last updated by the study team

2009-11-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GE Healthcare — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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