Clinical trial Recruiting at 2 sites Interventional Ages 1 Year to 26

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 typeInterventional
Ages1 Year to 26 Years
SexAll
Enrollment338 (estimated)
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Academic / other
Drugs / interventionsradiation
Locations2 sites (Washington D.C., District of Columbia and 1 other locations)
StatusRecruiting
StartedMay 17, 2023
Main results expectedDecember 2032
Study endsDecember 2035
Registry record updatedJune 29, 2026
Trial IDNCT05658731 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.