A Pilot Study to Evaluate Neurocognitive Injury and Longitudinal Changes in White Matter During Radiation Therapy in Children With Primary Brain Tumors
Stopped early · Not applicable
Conditions studied: Brain Tumor, Primary
In brief
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.
Key facts
- Study ID
- NCT02006407
- Run by
- University of Michigan Rogel Cancer Center
- People needed
- 5
- Starts
- 2013-06-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2016-12-30
Who can join
Age: 6 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Michigan Cancer Center — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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