FLT-PET Imaging of Brain Tumors in Children

Trial ID or NCT#

NCT01244737

Status

not recruiting iconNOT RECRUITING

Purpose

Brain tumors are the leading cause of death from solid tumors in children. Tumor imaging is important in the management of these tumors, but current imaging methods have limitations in providing the necessary information for optimal treatment of these patients. The goal of this study is to evaluate the potential utility of positron emission tomography (PET) with 3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) in the medical management of brain tumors in children. Funding source - FDA Office of Orphan Product Development (OOPD)

Official Title

Phase 2 Study of [18F]FLT for PET Imaging of Brain Tumors in Children

Eligibility Criteria

Ages Eligible for Study: Younger than 21 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - age 21 years or less - capable of achieving imaging without need for sedation or anesthesia (typically age 8 years or greater, but there is no lower limit for age for eligibility) - Karnofsky Performance Status of 50 or greater in subjects age 12 years or greater, for age less than 12 years a Lansky play scale of 50% or greater - Patients receiving steroids and/or anti-seizure medications are eligible
Exclusion Criteria:
  1. - clinically active infection - pregnancy or breast-feeding - serious intercurrent medical illness - require emergency surgical intervention that would be inappropriately delayed by FLT-PET imaging
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Investigator(s)

Michelle Monje
Paul Graham Fisher, MD
Paul Graham Fisher, MD
Neuro-oncologist, Pediatric neurologist
Beirne Family Professor of Pediatric Neuro-Oncology, Professor of Pediatrics and, by courtesy, of Neurosurgery and of Epidemiology and Population Health

Contact us to find out if this trial is right for you.

Contact

Leah White
650-725-4708

View on ClinicalTrials.gov