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

NCT06185686 | Recruiting

• 1 other identifier: 202312104
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Brain Tumor, Primary

Keywords

Proton therapy; Radiation; Brain tumor

Outcome Measures

Primary Outcomes (3)

• Radiation induced effects on functional brain resting state connectivity

  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.

  Through 1 year follow-up

• Baseline characteristics of functional network architecture

  The investigators will assess the unique architecture of brain networks at diagnosis and how significantly this architecture diverges from average healthy controls.

  At baseline (day 1)

• Change in characteristics of functional network architecture

  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.

  Baseline and 1 year follow-up

Secondary Outcomes (1)

• Correlation of radiation dose to changes in cognitive performance and resting state network connectivity

  At 1 year follow-up

Study Arms (1)

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

Other: Cognitive testing; Device: Resting State MRI/Precision functional mapping

Interventions

Cognitive testing OTHER

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

Brain tumor patients receiving proton radiation therapy

Resting State MRI/Precision functional mapping DEVICE

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

Also known as: RSFC MRI

Brain tumor patients receiving proton radiation therapy

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Treated at Siteman Cancer Center at Washington University School of Medicine.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• United States Department of Defense: collaborator
• The Foundation for Barnes-Jewish Hospital: collaborator
• Children's Cancer Research Fund: collaborator

Study Sites (1)

Washington University School of Medicine/Saint Louis Children's Hospital

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Stephanie Perkins, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Perkins, M.D.

CONTACT

314-747-4405; sperkins@wustl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 29, 2023
• Study Start: July 10, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)