NCT05658731Recruiting
Cognitive Outcomes After Brain Substructure-informed Radiation Planning in Pediatric Patients
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
The goal of this trial is to determine whether it is possible to minimize radiation dose to parts of the brain that are important for thinking and learning in children who require radiation to treat their tumor, and if this will help reduce neurocognitive (thinking and learning) impairments in these patients. Patients with newly diagnosed brain or head and neck tumors who are having radiation therapy will have neurocognitive testing and MRI imaging (both research and for regular care) done as part of their participation in the study. Survivors of childhood brain tumors who completed radiation therapy at least two years before joining the study, and have not had a recurrence, will have neurocognitive testing and research MRIs completed. Healthy children will also be enrolled and have research MRIs done. The researchers will use the radiation plan to determine how much radiation was delivered to different parts of the brain. The investigators will use the MRIs to determine how the normal brain is changing after treatment; and how this compares to patients who had standard radiation treatment or who never had a brain tumor. The neurocognitive testing will be compared among different groups to see how different treatment plans affect performance on neurocognitive tests.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 338 (estimated)
- First submitted
- 31 Oct 2022
- Start date
- 17 May 2023
- Primary completion date
- Dec 2032
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Head and neck cancer, Childhood cancers
- NCT number
- NCT05658731
What you commit to
- Study type: Interventional
- Planned participants: 338
- From 17 May 2023 to the primary completion date, Dec 2032
- 2 sites 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.
Criteria the registry did not label
- STRATUM A
- 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
- 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
- STRATUM B
- 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
- 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
- STRATUM C
- Eligibility Criteria
- must be aged 5 to \<26 years of age
- must be able to complete research imaging without sedation
- Exclusion Criteria
- must not have any major psychiatric, neurologic or medical diagnosis
Age in the registry: 1 year to 26 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Sibley Memorial Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.