[F-18]Fluoro-DOPA PET Imaging of Brain Tumors in Children
5 Years
15 Years
Both
Brain Tumors
Trial Information
[F-18]Fluoro-DOPA PET Imaging of Brain Tumors in Children
The first phase of the study will investigate if there is increased uptake of [F-18]FDOPA in
pediatric brain tumors when compared to normal brain tissue. Tne subjects between ages 5 and
17 years will be studies, to determine if there is increased uptake of [F-18]FDOPA in
pediatric brain tumors when compared to normal brain tissue. Drug safety will also be
monitored.
Inclusion Criteria:
- Documented brain tumor at diagnosis or relapse, including high grade glioma, low
grade glioma, medulloblastoma including PNET, optic pathway glioma, brainstem glioma,
ependymoma.
Exclusion Criteria:
- Pregnancy
- Requirement for sedation
- Lack of informed consent
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Increased uptake of [F-18]FDOPA in pediatric brain tumors compared to contralateral normal brain tissue as measured by standardized uptake value and tumor/non-tumor uptake ratios
Outcome Time Frame:
15-30 minutes after IV administration
Safety Issue:
No
Principal Investigator
Michael J Gelfand, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cincinnati Children's Hospital, Cincinnati, OH
Authority:
United States: Food and Drug Administration
Study ID:
CCHMC IRB# 04-09011
NCT ID:
NCT00556153
Start Date:
February 2013
Completion Date:
February 2013
Related Keywords:
- Brain Tumors
- brain tumors, children
- Brain Neoplasms
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