I-123-MIBG for Imaging of Neuroblastoma and Pheochromocytoma

This study has been completed.

Sponsor:

Collaborator:

University of Cincinnati

Information provided by:

Children's Hospital Medical Center, Cincinnati

ClinicalTrials.gov Identifier:

NCT00590096

First received: December 27, 2007

Last updated: August 24, 2009

Last verified: January 2007

History of Changes

Purpose

I-123-MIBG is used to image patients with neuroblastoma, pheochromocytoma and other neural crest tumors

Condition
Neuroblastoma Pheochromocytoma

Study Type:	Observational
Study Design:	Observational Model: Case-Only
Official Title:	I-123-MIBG for Imaging of Neuroblastoma and Pheochromocytoma

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary paraganglioma-pheochromocytoma neuroblastoma nonsyndromic paraganglioma

MedlinePlus related topics: Neuroblastoma Pheochromocytoma

Drug Information available for: Iobenguane sulfate I 123

U.S. FDA Resources

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Enrollment:	1380
Study Start Date:	January 1991
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Detailed Description:

Entry criteria--Histologically documented neuroblastoma or pheochromocytoma or strong suspicion of neuroblastoma or pheochromocytoma.

Exclusion criteria--Pregnancy Randomization--None Procedure--Patients will receive a dose of I-123-MIBG by intravenous injection. Images will obtained at 18-24 hours after administration of the drug and at 42-48 hours as needed. SSKI will be used to block thyroid uptake of free I-123-iodide

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with histologically proven neuroblastoma or pheochromocytoma or strong suspicion of neuroblastoma or pheochromocytoma

Criteria

Inclusion Criteria:

Histologically proven neuroblastoma or pheochromocytoma or strong suspicion of neuroblastoma or pheochromocytoma

Exclusion Criteria:

Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590096

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

University of Cincinnati

Investigators

Principal Investigator:

Michael J Gelfand, M.D.

Children's Hospital Medical Center, Cincinnati

More Information

Publications:

Gelfand MJ, Elgazzar AH, Kriss VM, Masters PR, Golsch GJ. Iodine-123-MIBG SPECT versus planar imaging in children with neural crest tumors. J Nucl Med. 1994 Nov;35(11):1753-7.

Paltiel HJ, Gelfand MJ, Elgazzar AH, Washburn LC, Harris RE, Masters PR, Golsch GJ. Neural crest tumors: I-123 MIBG imaging in children. Radiology. 1994 Jan;190(1):117-21.

Englaro EE, Gelfand MJ, Harris RE, Smith HS. I-131 MIBG imaging after bone marrow transplantation for neuroblastoma. Radiology. 1992 Feb;182(2):515-20.

Elgazzar AH, Gelfand MJ, Washburn LC, Clark J, Nagaraj N, Cummings D, Hughes J, Maxon HR 3rd. I-123 MIBG scintigraphy in adults. A report of clinical experience. Clin Nucl Med. 1995 Feb;20(2):147-52.

Chan EL, Harris RE, Emery KH, Gelfand MJ, Collins MH, Gruppo RA. Favorable histology, MYCN-amplified 4S neonatal neuroblastoma. Pediatr Blood Cancer. 2007 Apr;48(4):479-82. Review.

Gelfand MJ. 123I-MIBG uptake in the neck and shoulders of a neuroblastoma patient: damage to sympathetic innervation blocks uptake in brown adipose tissue. Pediatr Radiol. 2004 Jul;34(7):577-9. Epub 2004 Mar 3.

Gelfand MJ. Meta-iodobenzylguanidine in children. Semin Nucl Med. 1993 Jul;23(3):231-42. Review.

Responsible Party:	Michael J. Gelfand M.D., Cincinnati Children's Hospital
ClinicalTrials.gov Identifier:	NCT00590096 History of Changes
Other Study ID Numbers:	CCHMC# 88-12-2
Study First Received:	December 27, 2007
Last Updated:	August 24, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Children's Hospital Medical Center, Cincinnati:

Neuroblastoma
Pheochromocytoma
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

ClinicalTrials.gov processed this record on May 16, 2013

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