- Subject must either have:
1. known or suspected neuroblastoma OR
2. known or suspected phaeochromocytoma
- Subjects are not eligible for the study if they have any clinically active, serious,
life-threatening disease other than neuroblastoma or phaeochromocytoma with a life
expectancy of less than 30 days or where participation in the study might compromise
the management of the subject or other reason that in the judgement of the
investigator(s) makes the subject unsuitable for participation in the study.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
- To demonstrate that 123I-mIBG planar scintigraphy is sensitive and specific in confirming or excluding the diagnoses of neuroblastoma and phaeochromocytoma.
United States: Food and Drug Administration
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