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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by:

GE Healthcare

Study Description

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 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 or disease	Intervention/treatment
Neuroblastoma	Drug: Iobenguane I 123 Injection

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.

Study Design

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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Neuroblastoma

MedlinePlus related topics: Neuroblastoma

Drug Information available for: Iobenguane I 123 Iodine I-123

Genetic and Rare Diseases Information Center resources: Neuroblastoma Neuroepithelioma

U.S. FDA: Expanded Access (Compassionate Use)

U.S. FDA Resources

Interventions

Intervention Details:

Drug: Iobenguane I 123 Injection
1-10 mCi administered intravenously

Other Name: AdreView

Eligibility Criteria

Information from the National Library of Medicine

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

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540

Sponsors and Collaborators

GE Healthcare

Investigators

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Principal Investigator:	Arnold Jacobson, MD	GE Healthcare

More Information

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Responsible Party:	Arnold F. jacobson, M.D., PhD./Clinical Project Leader, GE Healthcare Ltd. and its affiliates
ClinicalTrials.gov Identifier:	NCT00730444
Other Study ID Numbers:	GE 122-008
First Posted:	August 8, 2008 Key Record Dates
Last Update Posted:	November 9, 2009
Last Verified:	November 2009

Keywords provided by GE Healthcare:


Neuroblastoma Nuclear medicine Diagnostic scintigraphy Known and suspected neuroblastoma

Additional relevant MeSH terms:

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Neuroblastoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms	Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue 3-Iodobenzylguanidine Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Radiopharmaceuticals

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