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

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Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00730444
First received: August 5, 2008
Last updated: November 5, 2009
Last verified: November 2009

August 5, 2008
November 5, 2009
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Complete list of historical versions of study NCT00730444 on ClinicalTrials.gov Archive Site
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Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma
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
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Neuroblastoma
Drug: Iobenguane I 123 Injection
1-10 mCi administered intravenously
Other Name: AdreView
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Approved for marketing
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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.
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00730444
GE 122-008
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Arnold F. jacobson, M.D., PhD./Clinical Project Leader, GE Healthcare Ltd. and its affiliates
GE Healthcare
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Principal Investigator: Arnold Jacobson, MD GE Healthcare
GE Healthcare
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP