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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00730444
Expanded Access Status : Approved for marketing
First Posted : August 8, 2008
Last Update Posted : November 9, 2009
Information provided by:
GE Healthcare

August 5, 2008
August 8, 2008
November 9, 2009
Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma
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.
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.
Expanded Access
Drug: Iobenguane I 123 Injection
1-10 mCi administered intravenously
Other Name: AdreView
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Approved for marketing
Contact information is only displayed when the study is recruiting subjects
United States
Arnold F. jacobson, M.D., PhD./Clinical Project Leader, GE Healthcare Ltd. and its affiliates
GE Healthcare
Not Provided
Principal Investigator: Arnold Jacobson, MD GE Healthcare
GE Healthcare
November 2009