Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma
Approved for marketing
GE Healthcare
1969-12-31
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.
Cardiac Resynchronization and Iodine Meta-Iodobenzylguanidine (MIBG) Imaging
Terminated
GE Healthcare
Phase 1
2012-02-01
Subjects were recruited if their healthcare provider decided that they needed treatment with
a special Internal Cardiac Defibrillator (ICD) called a biventricular ICD. The investigators
did this study to see if part of the nerve organ, called the sympathetic nervous system, may
be responsible for the improvement seen in patients that receive biventricular pacing. The
investigators had three ways to measure sympathetic nervous activity: 1) by using a special
blood sample, 2) by monitoring heart rhythm, and 3) by performing a special heart scan.
Cardiac Resynchronization and Iodine Meta-Iodobenzylguanidine (MIBG) Imaging
Terminated
Mayo Clinic
Phase 1
2012-02-01
Subjects were recruited if their healthcare provider decided that they needed treatment with
a special Internal Cardiac Defibrillator (ICD) called a biventricular ICD. The investigators
did this study to see if part of the nerve organ, called the sympathetic nervous system, may
be responsible for the improvement seen in patients that receive biventricular pacing. The
investigators had three ways to measure sympathetic nervous activity: 1) by using a special
blood sample, 2) by monitoring heart rhythm, and 3) by performing a special heart scan.
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