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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
  Purpose

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
Neuroblastoma
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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730444

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

No publications provided

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

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

Additional relevant MeSH terms:
Neuroblastoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral

ClinicalTrials.gov processed this record on November 23, 2014