Minimizing radiation impact on cognitive function in children with brain tumors
Official title: Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients
Run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · NCT05658731 · Data updated 2026-11-12
This study is testing if a special way of planning radiation treatment can help protect the thinking skills of children with brain tumors while they receive their therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Year to 26 Years |
| Sex | All |
| Enrollment | 338 (estimated) |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Status | Recruiting |
| Started | May 17, 2023 |
| Main results expected | December 2032 |
| Study ends | December 2035 |
| Registry record updated | June 29, 2026 |
| Trial ID | NCT05658731 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include children aged 1 to 26 years with newly diagnosed brain or head and neck tumors requiring radiation therapy.
✕Probably not a fit
Patients who are pregnant or unable to undergo neurocognitive testing due to developmental disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial aims to assess whether targeted radiation planning can reduce exposure to brain areas critical for cognitive function in pediatric patients undergoing treatment for brain or head and neck tumors. Participants will undergo neurocognitive testing and MRI imaging to evaluate the effects of radiation on brain structure and function. The study includes newly diagnosed patients, survivors of childhood brain tumors, and healthy children for comparison. The goal is to determine if minimizing radiation to specific brain substructures can help preserve cognitive abilities in these young patients.
Why it matters
Potential benefit: If successful, this approach could significantly reduce neurocognitive impairments in children receiving radiation therapy for brain tumors.
How similar studies have gone: Previous studies have shown promise in using targeted radiation approaches to minimize cognitive side effects, suggesting potential success for this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
1. STRATUM A
1. Eligibility Criteria
* aged 1 to \<26 years of age
* tumor must be located in the brain or adjacent to the brain including but not limited to nasopharynx, paranasal sinuses and orbit
* treatment must include radiation therapy (either proton or photon)
* patients must not have completed radiation therapy
2. Exclusion Criteria
* pregnancy
* patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological/neurodevelopmental disorders such as Down's syndrome or autism
2. STRATUM B
1. Eligibility Criteria
* diagnosed with a brain tumor at \<26 years of age
* received radiation to the brain as part of therapy
* time from radiation start to study enrollment is ≥ 2 years
* there has not been disease recurrence from time of most recent radiation treatment to study enrollment
2. Exclusion Criteria
* patients who are not able to undergo neuro-cognitive testing, including children lacking English comprehension or children with premorbid neurological/neurodevelopmental disorders such as Down's syndrome or autism
3. STRATUM C
1. Eligibility Criteria
* must be aged 5 to \<26 years of age
* must be able to complete research imaging without sedation
2. Exclusion Criteria
* must not have any major psychiatric, neurologic or medical diagnosis
Where it's running
-
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States Recruiting -
Johns Hopkins Hospital
Baltimore, Maryland, United States Recruiting
Study contacts
- Principal investigator: Sahaja Acharya, MD — Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Study coordinator: Sahaja Acharya, MD
- Email: sachary7@jhmi.edu
- Phone: 202-537-4788
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.