Minimizing radiation impact on cognitive function in children with brain tumors

Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 338 (estimated)
• Ages: 1 Year to 26 Years
• Sex: All
• 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)
• Trial ID: NCT05658731 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include children aged 1 to 26 years with newly diagnosed brain or head and neck tumors requiring radiation therapy.

Not a fit: Patients who are pregnant or unable to undergo neurocognitive testing due to developmental disorders may not benefit from this study.

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 performed: Previous studies have shown promise in using targeted radiation approaches to minimize cognitive side effects, suggesting potential success for this trial.

Eligibility 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 this trial is running

Washington D.C., District of Columbia and 1 other locations

• 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

Conditions Brain Tumor; Head and Neck Cancer; radiation therapy; pediatric