Clinical trial · Interventional
A Pilot Study to Evaluate Neurocognitive Injury and Longitudinal Changes in White Matter During Radiation Therapy in Children With Primary Brain Tumors
NCT02006407CI-TRIAL-00025297terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Trial closed due to low accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor, Primary | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cranial Radiotherapy | Radiation | — | UNRESOLVED |
| MRI with Diffusion Tensor Imaging (DTI) | Device | — | UNRESOLVED |
| Neuro-cognitive Testing (CogState) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Primary Brain Tumor
- description
- Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).
- interventionNames
- Radiation: Cranial Radiotherapy
- Device: MRI with Diffusion Tensor Imaging (DTI)
- Behavioral: Neuro-cognitive Testing (CogState)
Primary outcomes (1)
- measure
- Evaluate the Change From Baseline in Perpendicular Diffusivity of Water as Measured by Diffusion Tensor Imaging (DTI) at 3 Weeks and at 6 Weeks Post Radiation Therapy.
- timeFrame
- Baseline, 3 weeks, and 6 weeks
- description
- Descriptive statistics and plots will be used to determine Diffusion Tensor Imaging (DTI) parameters for various regions in the brain. The mean (across subject) change in DTI parameter for a given region, at a given time, will be used to assess white matter injury.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.