GE Healthcare has recently submitted a New Drug Application (NDA) for Iobenguane I 123Injection ([123I]mIBG (AdreView)) as a diagnostic nuclear imaging agent for the detectionof primary or metastatic neuroblastoma and pheochromocytoma. The present protocolestablishes an Expanded Access program to provide AdreView to pediatric medical centersand hospitals that treat neuroblastoma patients. AdreView will be provided for use indiagnostic assessment of patients with known or suspected neuroblastoma for whom there isan appropriate clinical indication for [123I]mIBG imaging.
The sponsor will provide [123I]mIBG as a single dose in a ready-to-use vial. All patients
greater than or equal to 18 years of age and children with a weight of greater than or
equal to 70 kg will receive an intravenous injection of 370 ±10% MBq (333 to 407 MBq [9.0
to 11 mCi]) of [123I]mIBG. Children <16 years of age (with a weight of 8-70 kg) will
receive an activity of [123I]mIBG calculated on the basis of a reference activity for an
adult scaled to body weight. Each investigator is responsible for obtaining the
appropriate thyroid blockade agent and for its administration in accordance with national
and local regulations and guidelines. Approximately 24 (± 6) hours following
administration of [123I]mIBG all patients will return to the clinic for scintigraphic
imaging. Imaging will be performed as per the standard procedures of the investigational
site. This should include at a minimum total body planar scintigraphy. Single photon
emission computed tomography (SPECT) may be performed following planar scintigraphy, as
appropriate.
Drug: Iobenguane I 123 Injection
1-10 mCi administered intravenously
Other Name: AdreView
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.
GE Healthcare
Princeton, New Jersey, United States
Arnold Jacobson, MD, Principal Investigator
GE Healthcare