Clinical trial NCT06185686: Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients
Official title: Assessing Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Tumor, Primary
Keywords: Proton therapy
Radiation
Brain tumor
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: The Foundation for Barnes-Jewish Hospital
First posted: 2023-12-29
Enrollment: 16
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treated at Siteman Cancer Center at Washington University School of Medicine.

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.


Eligibility 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 (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

Primary outcomes:
measure: Radiation induced effects on functional brain resting state connectivity
timeFrame: Through 1 year follow-up
measure: Baseline characteristics of functional network architecture
timeFrame: At baseline (day 1)
measure: Change in characteristics of functional network architecture
timeFrame: Baseline and 1 year follow-up
Secondary outcomes:
measure: Correlation of radiation dose to changes in cognitive performance and resting state network connectivity
timeFrame: At 1 year follow-up
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine/Saint Louis Children's Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Stephanie Perkins, M.D.
role: PRINCIPAL_INVESTIGATOR
References: