Skip to content

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06185686
Enrollment
16
Registered
2023-12-29
Start date
2024-07-10
Completion date
2027-07-31
Last updated
2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor, Primary

Keywords

Proton therapy, Radiation, Brain tumor

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.

Interventions

OTHERCognitive testing

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

DEVICEResting State MRI/Precision functional mapping

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

Sponsors

Washington University School of Medicine
Lead SponsorOTHER
United States Department of Defense
CollaboratorFED
The Foundation for Barnes-Jewish Hospital
CollaboratorOTHER
Children's Cancer Research Fund
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 21 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Radiation induced effects on functional brain resting state connectivityThrough 1 year follow-upThe 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 architectureAt 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 architectureBaseline and 1 year follow-upThe 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

MeasureTime frameDescription
Correlation of radiation dose to changes in cognitive performance and resting state network connectivityAt 1 year follow-upIn 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.

Countries

United States

Contacts

CONTACTStephanie Perkins, M.D.
sperkins@wustl.edu314-747-4405
PRINCIPAL_INVESTIGATORStephanie Perkins, M.D.

Washington University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026