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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-21
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cognitive testing

    Other intervention

    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.

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: Brain tumor patients receiving proton radiation therapy2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Through 1 year follow-up
2

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.

Time frame
At baseline (day 1)
3

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.

Time frame
Baseline and 1 year follow-up

Secondary outcomes

1

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.

Time frame
At 1 year follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

United States Department of Defense

Collaborator

The Foundation for Barnes-Jewish Hospital

Collaborator

Children's Cancer Research Fund

Collaborator