Status:
APPROVED_FOR_MARKETING
Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma
Lead Sponsor:
GE Healthcare
Conditions:
Neuroblastoma
Eligibility:
All Genders
Brief 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 metasta...
Detailed Description
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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00730444
Last Update
November 9 2009
Active Locations (1)
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1
GE Healthcare
Princeton, New Jersey, United States, 08540