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

This study has been withdrawn prior to enrollment.
(No participants ever enrolled.)
Sponsor:
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
History of Changes
  Purpose

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.


Condition Intervention
Brain Tumors
 Drug: [F-18]Fluoro-DOPA PET, a diagnostic radiopharmaceutical

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: [F-18]Fluoro-DOPA PET Imaging of Brain Tumors in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: February 2013
Estimated Study Completion Date: February 2013
Groups/Cohorts Assigned Interventions
Phase I
Children, ages 5-15 years with brain tumors
 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.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children ages 5-15 years, with brain tumors

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556153

Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Michael J Gelfand, M.D. Cincinnati Children's Hospital, Cincinnati, OH
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00556153     History of Changes
Other Study ID Numbers: CCHMC IRB# 04-09011
Study First Received: November 7, 2007
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Medical Center, Cincinnati:
brain tumors, children

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Dihydroxyphenylalanine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013