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

Recruiting

• Conditions: Brain Tumor, Primary
• Interventions: Other: Cognitive testing; Device: Resting State MRI/Precision functional mapping

• Registration Number: NCT06185686
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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 u...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2023-12-14
• Study First Posted: 2023-12-29
• Status Verified: 2024-07
• Study Start: 2024-07-10
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Brain tumor patients receiving proton radiation therapy	Resting State MRI/Precision functional mapping	Patients between 8 and 21 years old (inclusive) with a newly diagnosed primary brain tumor that will be treated with proton radiation therapy
Brain tumor patients receiving proton radiation therapy	Cognitive testing	Patients between 8 and 21 years old (inclusive) with a newly diagnosed primary brain tumor that will be treated with proton radiation therapy

Primary Outcome Measures

Name	Time	Method
Radiation induced effects on functional brain resting state connectivity	Through 1 year follow-up	The investigators will compare resting state maps of each patient pre- and post-radiation therapy. The investigators will evaluate changes in the resting state architecture and compare to the average results that would be expected from a patient in the same age and sex.
Baseline characteristics of functional network architecture	At baseline (day 1)	The investigators will assess the unique architecture of brain networks at diagnosis and how significantly this architecture diverges from average healthy controls.
Change in characteristics of functional network architecture	Baseline and 1 year follow-up	The investigators will assess brain system segregation which is measure of the connection and disconnection between different brain networks. These will be compared within individuals and compared to healthy controls.

Secondary Outcome Measures

Name	Time	Method
Correlation of radiation dose to changes in cognitive performance and resting state network connectivity	At 1 year follow-up	In an exploratory fashion, the investigators will evaluate the dose of radiation received to each resting state network to determine if functional connectivity changes in a dose dependent manner at 1 year.

Trial Locations

Locations (1)

Washington University School of Medicine/Saint Louis Children's Hospital; 🇺🇸 Saint Louis, Missouri, United States