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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Tumor, Primary
• Intervention / Treatment: Other: Cognitive testing; Device: Resting State MRI/Precision functional mapping

• Study Type: Observational
• Enrollment (Estimated): 16

Contacts and Locations

• Study Contact: Name: Stephanie Perkins, M.D.; Phone Number: 314-747-4405; Email: sperkins@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine/Saint Louis Children's Hospital
      • Sub-Investigator: Joshua Shimony, M.D., Ph.D.
      • Contact: Stephanie Perkins, M.D.; Phone Number: 314-747-4405; Email: sperkins@wustl.edu
      • Principal Investigator: Stephanie Perkins, M.D.
      • Sub-Investigator: Scott Marek, Ph.D.
      • Sub-Investigator: Margaret Shatara, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; NIH Toolbox Cognitive Battery and the Novel Cognitive Measure (NCM); Device: Resting State MRI/Precision functional mapping; At baseline (before the end of radiation therapy) and approximately 12 months after the completion of radiation therapy.; Other Names: RSFC MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of radiation dose to changes in cognitive performance and resting state network connectivity	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.	At 1 year follow-up

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: United States Department of Defense; The Foundation for Barnes-Jewish Hospital; Children's Cancer Research Fund
• Investigators: Principal Investigator: Stephanie Perkins, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Brain tumor; Radiation; Proton therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 202312104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No