Effects of Proton Beam Radiotherapy on Brain Function and Quality of Life in Young Patients
Neuroimaging Biomarkers of Impaired Neurocognitive Functioning After Cranial Proton Beam Radiotherapy For Treatment of Brain Tumors In Pediatric Patients
This study tests how proton beam radiotherapy affects brain function and quality of life in children and young adults with brain tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 25 Years |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05288439 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of proton beam radiotherapy (PBRT) on brain function and quality of life in children and young adults aged 6 to 25 who are undergoing treatment for brain tumors. Researchers will utilize resting state functional connectivity magnetic resonance imaging (rs-fcMRI) to assess changes in brain networks post-treatment. Additionally, participants will undergo cognitive assessments and complete questionnaires to evaluate their thinking abilities and overall quality of life. The study includes both patients receiving PBRT and healthy controls for comparative analysis.
Who should consider this trial
Good fit: Ideal candidates include children and young adults aged 6 to 25 diagnosed with primary or metastatic brain tumors who are recommended for cranial PBRT.
Not a fit: Patients who are unable to tolerate MRI without sedation or those with major medical illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how PBRT affects cognitive function and quality of life, potentially leading to improved treatment strategies for young patients with brain tumors.
How similar studies have performed: Other studies have explored the effects of radiotherapy on cognitive function, but this specific approach using rs-fcMRI in young patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients Treated for Brain Tumors: * The patient has been diagnosed with a primary or metastatic brain tumor * The patient has been recommended to receive cranial PBRT for a primary or metastatic brain tumor * The patient is between the ages of 6 through 25 at time of consent * As per medical record or patient report (based on prior tolerance of MRI), the participant is able to tolerate MRI without sedation (i.e., general anesthesia). Patients will take medications as prescribed or directed by the patient's physician. If in accordance with their prescribed regimen, agents that may impact the CNS, such as benzodiazepines and/or antihistamines, should be avoided on the day of imaging and neurocognitive assessment. Healthy Control Participants: * The control has no major medical illness, as determined by medical interview by study physician * As per parent report, the control is between the ages of 6 through 25 at time of consent * As per parent report, the control is able to tolerate an MRI without sedation (i.e., general anesthesia). Participants should only take medications as prescribed or directed by their physician. They should not take additional medications, such as antihistamines, for the purpose of tolerating MR imaging. Exclusion Criteria: * As per self or parent report, the participant has completed any portion of the neuropsychological battery used in this study within the last year. * As per medical record or self or parent report, there is an existing diagnosis of intellectual disability and/or prior IQ testing that documents Full Scale IQ standard score \<70 at baseline. * As per medical record, there is an existing diagnosis of psychiatric disorder or untreated mood disturbance, prior stroke or intracranial hemorrhage, or neurodegenerative disease. * The participant has an MRI contraindication (e.g., implanted ferromagnetic devices, claustrophobia) as per radiology clinical operating procedures. * As per self or parent report, non-fluency in English language as demonstrated by current educational placement in a non-English-speaking classroom setting.
Where this trial is running
New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Andrei Holodny, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Andrei Holodny, MD
- Email: holodnya@mskcc.org
- Phone: 212-639-3182
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.