Clinical trial NCT00590096: I-123-MIBG for Imaging of Neuroblastoma and Pheochromocytoma
Official title: I-123-MIBG for Imaging of Neuroblastoma and Pheochromocytoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroblastoma
Pheochromocytoma
Keywords: Neuroblastoma
Pheochromocytoma
MIBG
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: University of Cincinnati
First posted: 2008-01-10
Enrollment: 1380
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically proven neuroblastoma or pheochromocytoma or strong suspicion of neuroblastoma or pheochromocytoma

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

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Michael J Gelfand, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1002/pbc.20705.
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. doi: 10.1007/s00247-003-1136-x. Epub 2004 Mar 3.
citation: Gelfand MJ. Meta-iodobenzylguanidine in children. Semin Nucl Med. 1993 Jul;23(3):231-42. doi: 10.1016/s0001-2998(05)80104-7.
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.
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. doi: 10.1148/radiology.190.1.8259387.
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. doi: 10.1148/radiology.182.2.1732972.
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. doi: 10.1097/00003072-199502000-00011.