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Brain-Sparing radiation may shield young minds from treatment side effects

NCT ID NCT05658731

Knowledge-focused Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study explores whether planning radiation therapy to avoid key brain regions can reduce thinking and learning problems in children with brain or head and neck tumors. Participants include children receiving radiation, survivors who completed radiation at least two years ago, and healthy children for comparison. Researchers will use MRI scans and cognitive tests to measure brain changes and mental performance over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radiation therapy with substructure-informed planning
What this could lead to
If successful, this approach could help preserve thinking and learning abilities in children who need radiation for brain or head and neck tumors.
What could go wrong
This is an early-stage feasibility study, so it may not prove that the planning method actually protects cognitive function. The results may not apply to all tumor types or radiation techniques.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 338 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Dec 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 26 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

brain cancer brain neoplasm head and neck cancer Head and Neck Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain tumor Head and neck cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Sibley Memorial Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20016, United States

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