Status:
RECRUITING
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
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Brain Tumor
Metastatic Brain Tumor
Eligibility:
All Genders
6-25 years
Phase:
NA
Brief 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 therap...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05288439
Start Date
March 7 2022
End Date
March 1 2026
Last Update
May 23 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065