Meta-Iodobenzylguanidine (123I mIBG) Scintigraphy in Patients Being Evaluated for Phaeochromocytoma or Neuroblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00126412
Recruitment Status : Completed
First Posted : August 4, 2005
Last Update Posted : May 16, 2007
Information provided by:
GE Healthcare

Brief Summary:
The study is designed to study the effectiveness of 123I-mIBG as a diagnostic imaging agent in evaluating patients with known or suspected neuroblastoma or phaeochromocytoma.

Condition or disease Intervention/treatment Phase
Pheochromocytoma Neuroblastoma Drug: 123I-mIBG (meta-iodobenzylguanidine) Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 185 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : July 2005

Primary Outcome Measures :
  1. - To demonstrate that 123I-mIBG planar scintigraphy is sensitive and specific in confirming or excluding the diagnoses of neuroblastoma and phaeochromocytoma.

Secondary Outcome Measures :
  1. To determine the incremental value of single-photon emission computed tomography (SPECT) for improving the sensitivity and specificity of 123I-mIBG planar scintigraphy for the diagnoses of neuroblastoma and phaeochromocytoma.
  2. To collect safety data on 123I-mIBG.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Subject must either have:

    1. known or suspected neuroblastoma OR
    2. known or suspected phaeochromocytoma
  • Subjects are not eligible for the study if they have any clinically active, serious, life-threatening disease other than neuroblastoma or phaeochromocytoma with a life expectancy of less than 30 days or where participation in the study might compromise the management of the subject or other reason that in the judgement of the investigator(s) makes the subject unsuitable for participation in the study.

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 identifier (NCT number): NCT00126412

United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Study Director: Diane McCaul GE Healthcare Identifier: NCT00126412     History of Changes
Other Study ID Numbers: MBG308
First Posted: August 4, 2005    Key Record Dates
Last Update Posted: May 16, 2007
Last Verified: May 2007

Keywords provided by GE Healthcare:

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
Neuroendocrine Tumors
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action