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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Mar 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how proton beam radiotherapy (PBRT), a type of targeted radiation treatment, affects brain function and quality of life in children and young adults aged 6 to 25 who are being treated for brain tumors. Researchers want to find out if there are differences in how the brain works after receiving PBRT by using a special type of brain scan called resting state functional connectivity MRI (rs-fcMRI). They will also assess thinking skills and overall quality of life through tests and questionnaires. The study includes both patients receiving PBRT and healthy participants, allowing researchers to compare brain connections and cognitive abilities between the two groups.

To participate, children and young adults must have a diagnosed primary or metastatic brain tumor and be recommended for PBRT. They should be able to tolerate an MRI without sedation, meaning they don’t need to be put to sleep for the scan. Healthy participants must not have any major medical issues and also be able to tolerate an MRI. Throughout the trial, participants can expect to undergo brain scans and complete cognitive assessments, which will help researchers understand the impact of PBRT on brain health and functioning. The findings from this study may help improve future treatments for brain cancer in young patients.

Gender

ALL

Eligibility 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.