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

NCT ID: NCT02006407

Last Updated: 2016-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Tumor, Primary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Primary Brain Tumor

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).

Group Type OTHER

Cranial Radiotherapy

Intervention Type RADIATION

Standard cranial radiotherapy administered dependent upon patient and brain tumor type.

MRI with Diffusion Tensor Imaging (DTI)

Intervention Type DEVICE

Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)

Neuro-cognitive Testing (CogState)

Intervention Type BEHAVIORAL

CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests.

Interventions

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Cranial Radiotherapy

Standard cranial radiotherapy administered dependent upon patient and brain tumor type.

Intervention Type RADIATION

MRI with Diffusion Tensor Imaging (DTI)

Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)

Intervention Type DEVICE

Neuro-cognitive Testing (CogState)

CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carl Koschmann, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

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University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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UMCC 2012.117

Identifier Type: -

Identifier Source: org_study_id