NCT00556153

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2013

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
5.2 years until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

First QC Date

November 7, 2007

Last Update Submit

January 7, 2013

Conditions

Brain Tumors

Keywords

brain tumors, children

Outcome Measures

Primary Outcomes (1)

  • 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

    15-30 minutes after IV administration

Study Arms (1)

Phase I

Children, ages 5-15 years with brain tumors

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

Interventions

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

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

Phase I

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children ages 5-15 years, with brain tumors

You may qualify if:

  • Documented brain tumor at diagnosis or relapse, including high grade glioma, low grade glioma, medulloblastoma including PNET, optic pathway glioma, brainstem glioma, ependymoma.

You may not qualify if:

  • Pregnancy
  • Requirement for sedation
  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Michael J Gelfand, M.D.

    Cincinnati Children's Hospital, Cincinnati, OH

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2007

First Posted

November 9, 2007

Study Start

February 1, 2013

Study Completion

February 1, 2013

Last Updated

January 8, 2013

Record last verified: 2013-01