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

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00126412
First received: August 2, 2005
Last updated: May 15, 2007
Last verified: May 2007
History of Changes
  Purpose

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
Pheochromocytoma
Neuroblastoma
 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:

U.S. FDA Resources

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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126412

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

No publications provided

ClinicalTrials.gov 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:
Phaeochromocytoma
Neuroblastoma
diagnosis
123I-mIBG

Additional relevant MeSH terms:
Neuroblastoma
Pheochromocytoma
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
Paraganglioma
Neuroendocrine Tumors
3-Iodobenzylguanidine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013