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

This study has been completed.
Information provided by:
GE Healthcare Identifier:
First received: August 2, 2005
Last updated: May 15, 2007
Last verified: May 2007
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 Intervention Phase
Drug: 123I-mIBG (meta-iodobenzylguanidine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

Further study details as provided by GE Healthcare:

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

Secondary Outcome Measures:
  • 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.
  • To collect safety data on 123I-mIBG.

Estimated Enrollment: 185
Study Start Date: July 2005

Genders Eligible for Study:   Both
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.
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Please refer to this study by its identifier: NCT00126412

United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Study Director: Diane McCaul GE Healthcare
  More Information

No publications provided Identifier: NCT00126412     History of Changes
Other Study ID Numbers: MBG308
Study First Received: August 2, 2005
Last Updated: May 15, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by GE Healthcare:

Additional relevant MeSH terms:
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
Neuroendocrine Tumors
Antineoplastic Agents
Diagnostic Uses of Chemicals
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 25, 2015