I-123-MIBG for Imaging of Neuroblastoma and Pheochromocytoma
This study has been completed.
Sponsor:
Children's Hospital Medical Center, Cincinnati
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
| Tracking Information | |||||
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| First Received Date ICMJE | December 27, 2007 | ||||
| Last Updated Date | August 24, 2009 | ||||
| Start Date ICMJE | January 1991 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00590096 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | I-123-MIBG for Imaging of Neuroblastoma and Pheochromocytoma | ||||
| Official Title ICMJE | I-123-MIBG for Imaging of Neuroblastoma and Pheochromocytoma | ||||
| Brief Summary | I-123-MIBG is used to image patients with neuroblastoma, pheochromocytoma and other neural crest tumors |
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| 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 |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with histologically proven neuroblastoma or pheochromocytoma or strong suspicion of neuroblastoma or pheochromocytoma |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1380 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00590096 | ||||
| Other Study ID Numbers ICMJE | CCHMC# 88-12-2 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Michael J. Gelfand M.D., Cincinnati Children's Hospital | ||||
| Study Sponsor ICMJE | Children's Hospital Medical Center, Cincinnati | ||||
| Collaborators ICMJE | University of Cincinnati | ||||
| Investigators ICMJE |
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| Information Provided By | Children's Hospital Medical Center, Cincinnati | ||||
| Verification Date | January 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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