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

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

Condition Intervention
Drug: Iobenguane I 123 Injection

Study Type: Expanded Access     What is Expanded Access?
Official Title: Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma

Resource links provided by NLM:

Further study details as provided by GE Healthcare:

Intervention Details:
    Drug: Iobenguane I 123 Injection
    1-10 mCi administered intravenously
    Other Name: AdreView
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 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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All

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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Please refer to this study by its identifier: NCT00730444

United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Principal Investigator: Arnold Jacobson, MD GE Healthcare
  More Information

Responsible Party: Arnold F. jacobson, M.D., PhD./Clinical Project Leader, GE Healthcare Ltd. and its affiliates Identifier: NCT00730444     History of Changes
Other Study ID Numbers: GE 122-008
Study First Received: August 5, 2008
Last Updated: November 5, 2009

Keywords provided by GE Healthcare:
Nuclear medicine
Diagnostic scintigraphy
Known and suspected neuroblastoma

Additional relevant MeSH terms:
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals processed this record on April 25, 2017