A Pilot Study to Evaluate Neurocognitive Injury and Longitudinal Changes in White Matter During Radiation Therapy in Children With Primary Brain Tumors
Brain Tumor, Primary
Conditions: official terms
Brain Neoplasms
Study Type
Study Phase
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Name: Cranial Radiotherapy Type: Radiation
Name: MRI with Diffusion Tensor Imaging (DTI) Type: Device
Name: Neuro-cognitive Testing (CogState) Type: Behavioral
Overall Status
This is a pilot study to assess the changes in white matter, in the brain, in response to radiation therapy and correlate these changes with later declines in cognitive function.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 21 Years
Minimum Age: 6 Years
Gender: Both
Criteria: Inclusion Criteria:

- Pediatric patients (age 6-21) who will receive cranial radiotherapy for brian tumors. This could include but is not limited to: low grade glioma, high grade glioma (to include grade III but not grade IV glioma), germ cell tumors, primitive neuroectodermal tumors, craniopharyngioma, or medulloblastoma.

- Patients should, in the estimate of the treating physician, be anticipated to have a median survival of greater than 1 year.

Exclusion Criteria:

- Patients with previous Central Nervous System (CNS) radiation or or CNS tumors that, in the judgement of the investigators, are likely to undergo progression during or shortly after radiotherapy are excluded.

- Patients with glioblastoma, multiforme, gliosarcoma, diffuse pontine glioma, or other tumors presumed to have expected median survival per the investigators of less than 1 year.

- Patients who require sedation for Magnetic Resonance Imagining (MRI)are excluded.

- Patients at risk for nephrogenic systemic sclerosis will be excluded as a safety precaution due to the contrast used in the scans.
University of Michigan Cancer Center
Ann Arbor, Michigan, United States
Status: Recruiting
Contact: Daniel Hamstra, M.D., Ph.D. - 734-936-4300 - dhamm@umich.edu
Start Date
June 2013
University of Michigan Cancer Center
University of Michigan Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page