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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	8 Years - 21 Years
Gender	All

More Inclusion & Exclusion Criteria

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, 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06185686
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Washington University School of Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Stephanie Perkins, M.D.
Principal Investigator Affiliation	Washington University School of Medicine
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumor, Primary
Study Website:	View Trial Website

Arms & Interventions

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

Other: - Cognitive testing

NIH Toolbox Cognitive Battery, the ADHD Rating Scale, the Neuro-QOL, the CLDQ, and the PROMIS Parent Proxy for Cognition at baseline (prior to completion of second week of radiation therapy) and again approximately 12 months after the completion of radiation therapy.

Device: - Resting State MRI/Precision functional mapping

During standard of care MRI at pre-treatment and approximately 12 months after the completion of radiation therapy.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Saint Louis, Missouri

Status

Address

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

Saint Louis, Missouri, 63110

Site Contact

Stephanie Perkins, M.D.

sperkins@wustl.edu

314-747-4405

Clinical Trial Finder