[F-18]Fluoro-DOPA PET Imaging of Brain Tumors in Children

NCT ID: NCT00556153

Last Updated: 2013-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain Tumors

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Phase I

Children, ages 5-15 years with brain tumors

[F-18]Fluoro-DOPA PET, a diagnostic radiopharmaceutical

Intervention Type DRUG

A single dosage of the diagnostic drug will be administered to individuals who meet inclusion criteria after informed consent.

Interventions

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[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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael J Gelfand, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cincinnati Children's Hospital, Cincinnati, OH

Other Identifiers

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CCHMC IRB# 04-09011

Identifier Type: -

Identifier Source: org_study_id

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