I-123-MIBG for Imaging of Neuroblastoma and Pheochromocytoma

Neuroblastoma Clinical Trial

Official title:

I-123-MIBG for Imaging of Neuroblastoma and Pheochromocytoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590096
• Other study ID #: CCHMC# 88-12-2
• Status: Completed
• Phase: N/A
• First received: December 27, 2007
• Last updated: August 24, 2009
• Start date: January 1991
• Est. completion date: December 2008

Study information

• Verified date: January 2007
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1380
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Neuroblastoma
• Pheochromocytoma

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	University of Cincinnati

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation