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

Neuroblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT00730444
• Other study ID #: GE 122-008
• Status: Approved for marketing
• Phase: N/A
• First received: August 5, 2008
• Last updated: November 5, 2009

Study information

• Verified date: November 2009
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

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

Locations

Country	Name	City	State
United States	GE Healthcare	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States,