A Pilot Study to Evaluate Neurocognitive Injury and Longitudinal Changes in White Matter During Radiation Therapy in Children With Primary Brain Tumors

University of Michigan Rogel Cancer Center

Status: Terminated

Conditions: Brain Tumor, Primary

Treatments: Radiation: Cranial Radiotherapy; Device: MRI with Diffusion Tensor Imaging (DTI); Behavioral: Neuro-cognitive Testing (CogState)

Study type: Interventional

Funder types: Other

Identifiers

NCT02006407

UMCC 2012.117

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 6 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

Primary Brain Tumor

Other group

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).

Treatment:

Device: MRI with Diffusion Tensor Imaging (DTI)

Behavioral: Neuro-cognitive Testing (CogState)

Radiation: Cranial Radiotherapy