[F-18]Fluoro-DOPA PET Imaging of Brain Tumors in Children
This study has been withdrawn prior to enrollment.
(No participants ever enrolled.)
Sponsor:
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00556153
First received: November 7, 2007
Last updated: January 7, 2013
Last verified: January 2013
| Tracking Information | |||||
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| First Received Date ICMJE | November 7, 2007 | ||||
| Last Updated Date | January 7, 2013 | ||||
| Start Date ICMJE | February 2013 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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 [ Time Frame: 15-30 minutes after IV administration ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Increased uptake of [F-18]FDOPA in pediatric brain tumors compared to contralateral normal brain tissue as meased by stanfdardized uptake value and tumor/non-tumor uptake ratios [ Time Frame: 15-30 minutes after IV administration ] | ||||
| Change History | Complete list of historical versions of study NCT00556153 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 | [F-18]Fluoro-DOPA PET Imaging of Brain Tumors in Children | ||||
| Official Title ICMJE | [F-18]Fluoro-DOPA PET Imaging of Brain Tumors in Children | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Children ages 5-15 years, with brain tumors |
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| Condition ICMJE | Brain Tumors | ||||
| Intervention ICMJE | Drug: [F-18]Fluoro-DOPA PET, a diagnostic radiopharmaceutical
A single dosage of the diagnostic drug will be administered to individuals who meet inclusion criteria after informed consent. |
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| Study Group/Cohort (s) | Phase I
Children, ages 5-15 years with brain tumors
Intervention: Drug: [F-18]Fluoro-DOPA PET, a diagnostic radiopharmaceutical |
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| Publications * | Not Provided | ||||
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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 | Withdrawn | ||||
| Enrollment ICMJE | 0 | ||||
| Estimated Completion Date | February 2013 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 5 Years to 15 Years | ||||
| 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 | NCT00556153 | ||||
| Other Study ID Numbers ICMJE | CCHMC IRB# 04-09011 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Children's Hospital Medical Center, Cincinnati | ||||
| Study Sponsor ICMJE | Children's Hospital Medical Center, Cincinnati | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Children's Hospital Medical Center, Cincinnati | ||||
| Verification Date | January 2013 | ||||
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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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