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NCT Number: NCT06185686

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.

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Key information

Conditions

Brain Tumor, Primary Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Joshua Shimony, M.D., Ph.D.

SUB_INVESTIGATOR

Margaret Shatara, M.D.

SUB_INVESTIGATOR

Scott Marek, Ph.D.

SUB_INVESTIGATOR

Stephanie Perkins, M.D.

CONTACT

[email protected]

314-747-4405

Stephanie Perkins, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive testing

Other

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

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.

Other names: RSFC MRI

Primary outcomes

  1. Radiation induced effects on functional brain resting state connectivity

    Time frame: 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.

  2. Baseline characteristics of functional network architecture

    Time frame: 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.

  3. Change in characteristics of functional network architecture

    Time frame: 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 outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Perkins, M.D.

CONTACT

[email protected]

314-747-4405

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Children's Cancer Research Fund
  • The Foundation for Barnes-Jewish Hospital
  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 29, 2023
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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