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

NCT00730444 | Unknown

• 1 other identifier: GE 122-008
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroblastoma

Keywords

Neuroblastoma; Nuclear medicine; Diagnostic scintigraphy; Known and suspected neuroblastoma

Interventions

Iobenguane I 123 Injection DRUG

1-10 mCi administered intravenously

Also known as: AdreView

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Neuroblastoma

Interventions

3-Iodobenzylguanidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Iodobenzenes; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hydrocarbons, Iodinated; Hydrocarbons, Halogenated

Study Officials

• Arnold Jacobson, MD

  GE Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 8, 2008
• Last Updated: November 9, 2009

Record last verified: 2009-11

Locations

US (1)