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

Brain Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00556153
• Other study ID #: CCHMC IRB# 04-09011
• Status: Withdrawn
• Phase: N/A
• First received: November 7, 2007
• Last updated: January 7, 2013
• Start date: February 2013
• Est. completion date: February 2013

Study information

• Verified date: January 2013
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No