NCT05288439Active, not 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
Neuroimaging Biomarkers of Impaired Neurocognitive Functioning After Cranial Proton Beam Radiotherapy For Treatment of Brain Tumors In Pediatric Patients
Source: ClinicalTrials.gov · Last updated 23 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 8 Mar 2022
- Start date
- 7 Mar 2022
- Primary completion date
- Mar 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Childhood cancers
- NCT number
- NCT05288439
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 7 Mar 2022 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- As per self or parent report, the participant has completed any portion of the neuropsychological battery used in this study within the last year.
- 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.
Who the study is looking for
- 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.
Age in the registry: 6 years to 25 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.