Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-10

Study Completion Date

2027-07-31

Brief Summary

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With modern therapy, the survival rate for pediatric brain tumor patients has significantly improved, with over 70% of patients surviving their disease. However, this progress often comes at the cost of substantial morbidity, with cognitive deficits being the primary obstacle to independent living. Robust predictors of cognitive decline and a comprehensive understanding of the underlying mechanisms of cognitive injury remain elusive. This study will prospectively investigate alterations in brain resting state networks following radiation therapy using functional imaging. The hypothesis is that radiation therapy leads to dose-dependent alterations in functional connectivity in the networks associated with higher level cognition, ultimately leading to cognitive decline.

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Detailed Description

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Conditions

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Brain Tumor, Primary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Brain tumor patients receiving proton radiation therapy

Patients between 8 and 21 years old (inclusive) with a newly diagnosed primary brain tumor that will be treated with proton radiation therapy

Cognitive testing

Intervention Type OTHER

NIH Toolbox Cognitive Battery and the Novel Cognitive Measure (NCM)

Resting State MRI/Precision functional mapping

Intervention Type DEVICE

At baseline (before the end of radiation therapy) and approximately 12 months after the completion of radiation therapy.

Interventions

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Cognitive testing

NIH Toolbox Cognitive Battery and the Novel Cognitive Measure (NCM)

Intervention Type OTHER

Resting State MRI/Precision functional mapping

At baseline (before the end of radiation therapy) and approximately 12 months after the completion of radiation therapy.

Intervention Type DEVICE

Other Intervention Names

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RSFC MRI

Eligibility Criteria

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Inclusion Criteria

* Between 8 and 21 years of age, inclusive
* Newly diagnosed primary brain tumor of any location and any histology that will be treated with proton radiation therapy
* Life expectancy of at least one year
* Able to understand and willing to consent or assent to the research proposed (or that of a legally authorized representative, if applicable), along with consent of legal guardian(s) if applicable

Exclusion Criteria

* Presence of visual impairment to an extent that the patient is unable to complete the computer testing
* Contraindication to MRI scan (i.e. due to cardiac pacemaker)
* Presence of programmable shunt or dental braces
* Requires sedation for MRI scans

Minimum Eligible Age

8 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No