Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma
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|ClinicalTrials.gov Identifier: NCT00730444|
Expanded Access Status : Approved for marketing
First Posted : August 8, 2008
Last Update Posted : November 9, 2009
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|Condition or disease||Intervention/treatment|
|Neuroblastoma||Drug: Iobenguane I 123 Injection|
|Study Type :||Expanded Access|
|Official Title:||Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma|
- Drug: Iobenguane I 123 Injection
1-10 mCi administered intravenouslyOther Name: AdreView
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00730444
|United States, New Jersey|
|Princeton, New Jersey, United States, 08540|
|Principal Investigator:||Arnold Jacobson, MD||GE Healthcare|
|Responsible Party:||Arnold F. jacobson, M.D., PhD./Clinical Project Leader, GE Healthcare Ltd. and its affiliates|
|Other Study ID Numbers:||
|First Posted:||August 8, 2008 Key Record Dates|
|Last Update Posted:||November 9, 2009|
|Last Verified:||November 2009|
Known and suspected neuroblastoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Molecular Mechanisms of Pharmacological Action