Recruiting

Observational Study

Sponsor:

Washington University School of Medicine

Code:

NCT06185686

Conditions

Brain Tumor, Primary

Eligibility Criteria

Sex: All

Age: 8 - 21

Healthy Volunteers: Not accepted

Interventions

Cognitive testing

Resting State MRI/Precision functional mapping

Study Details

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

Study ID

NCT06185686

Start date

Jul 10, 2024

Status verified date

Jul, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 21

Healthy Volunteers: Not accepted

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 Design

Enrollment

16 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Cognitive testing

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

Resting State MRI/Precision functional mapping

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

Primary outcome measure

  • Radiation induced effects on functional brain resting state connectivity [ Time Frame: Through 1 year follow-up ]
  • Baseline characteristics of functional network architecture [ Time Frame: At baseline (day 1) ]
  • Change in characteristics of functional network architecture [ Time Frame: Baseline and 1 year follow-up ]

Central Contacts and Locations

Central contacts

Stephanie Perkins, M.D.

314-747-4405sperkins@wustl.edu

Locations

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

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Stephanie Perkins, M.D.

314-747-4405sperkins@wustl.edu

Principal Investigator:

Stephanie Perkins, M.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

  • Proton therapy
  • Radiation
  • Brain tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-17.