NCT05288439

A Study of How Proton Beam Radiotherapy (PBRT) Affects Brain Function and Quality of Life in Children and Young Adults Undergoing Treatment for a Brain Tumor

Neuroimaging Biomarkers of Impaired Neurocognitive Functioning After Cranial Proton Beam Radiotherapy For Treatment of Brain Tumors In Pediatric Patients

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 6 Years – 25 Years
• Healthy volunteers: Accepted

Summary

The researchers are doing this study to find out if there are differences in the resting state brain networks of children and young adults (ages 6-25) after treatment with proton beam radiation therapy (PBRT). The researchers will use resting state functional connectivity magnetic resonance imagining (rs-fcMRI) scanning to detect these differences. The researchers will also check for differences in participants' thinking and quality of life through a cognitive assessment and a questionnaire. Both people undergoing PBRT for a brain tumor and healthy people will take part in this study so that the researchers can compare the brain networks (connections in the brain that are involved in certain function, such as memory or attention), thinking patterns, and quality of life of these two groups of participants. The study researchers think that rs-fcMRI scans may be an effective way to look at the brain networks after treatment with PBRT and see if this treatment causes differences in those networks, including damage to the brain (neurotoxicity). rs-fcMRI scans take images when a patient is in a resting state, which means the patient is not performing a task or thinking about anything in particular. This study will provide valuable information about how PBRT affects brain networks, thinking (cognitive) abilities, and quality of life in children and young adults. The study results may have an impact on future treatment approaches for brain cancer and the use of PBRT in children and young adults.

Conditions

• Brain Tumor
• Metastatic Brain Tumor

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Resting-state functional connectivity MRI	participants will undergo functional MRI
OTHER	Neurocognitive battery with quality-of-life assessment	Cognitive and quality of life assessments performed by a trained neuropsychologist

Timeline

• Start date: 2022-03-07
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2022-03-21
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States