I-123-MIBG for Imaging of Neuroblastoma and Pheochromocytoma - Full Text View

Sponsors and Collaborators:	Children's Hospital Medical Center, Cincinnati University of Cincinnati
Information provided by:	Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:	NCT00590096

Purpose

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

Condition
Neuroblastoma Pheochromocytoma

MedlinePlus related topics: Neuroblastoma Pheochromocytoma

U.S. FDA Resources

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

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2000
Study Start Date:	January 1991
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (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

Contacts

Contact: Michael J Gelfand, M.D.

613-636-7650

michael.gelfand@cchmc.org

Locations

United States, Ohio
Cincinnati Children's Hospital	Recruiting
Cincinnati, Ohio, United States, 45215
Contact: Michael J Gelfand, M.D. 513-636-7650 michael.gelfand@cchmc.org
Principal Investigator: Michael J Gelfand, M.D.

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:	Cincinnati Children's Hospital ( Michael J. Gelfand M.D. )
Study ID Numbers:	CCHMC# 88-12-2
Study First Received:	December 27, 2007
Last Updated:	February 1, 2008
ClinicalTrials.gov Identifier:	NCT00590096 History of Changes
Health Authority:	United States: Food and Drug Administration

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

Neuroblastoma
Pheochromocytoma
MIBG

Study placed in the following topic categories:

Neuroectodermal Tumors
Paraganglioma
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Neuroectodermal Tumors, Primitive, Peripheral
Pheochromocytoma
Neuroblastoma
Neuroendocrine Tumors
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neuroectodermal Tumors, Primitive
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neuroblastoma
Pheochromocytoma
Neuroendocrine Tumors
Neuroectodermal Tumors

Neoplasms
Paraganglioma
Neoplasms, Germ Cell and Embryonal
Neoplasms, Neuroepithelial
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009