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Mapping the hidden toll of brain radiation on young minds

NCT ID NCT03972514

Knowledge-focused Sponsor: Baptist Health South Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study follows children and young adults (up to age 35) with brain or skull base tumors who are scheduled to receive radiation therapy to the brain. Researchers use brain scans to track changes in brain structure and volume over time. They also measure thinking skills, hormone levels, and quality of life to understand how radiation affects the developing brain. The goal is to link radiation dose to long-term effects, which could help design safer treatments in the future.

What this could mean

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

What this could lead to
If successful, this study could help doctors predict and reduce long-term side effects of brain radiation in children, improving quality of life.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new therapy. Results may not lead to immediate changes in care.

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.

Participants

60 people

The number who actually took part.

Started

Mar 2019

Expected to finish

Mar 2030

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.

Who is studied

The study sample size will be 60 patients. This sample size was selected to ensure an adequate distribution of primary tumor diagnoses and dosimetric variation in major brain substructures treated based on tumor location/brain regions treated. The estimated case distribution based on historical data from 2007-2015 will be: Craniopharyngioma 20%, Ependymoma 20%, Low Grade Glioma 20%, Medulloblastoma/PNET 15%, Sarcoma 10%, Other 15%.

Ages

1 year to 35 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Inclusion Criteria: * Patient (parent) must give study-specific informed consent on an IRB-approved consent prior to any research related procedures or study treatment. Written assent will be obtained as per Institutional guidelines. * Patients (Age equal to or less than 35 years old) that are planned to receive photon or proton RT to the brain according to standard of care are eligible to participate. * Patients that are planned to receive fractionated RT at 1.2-2.0 Gy RBE dose per fraction per standard of care are eligible to participate. If patients are planned to receive an alternative dose/fractionation regimen, then they should be treated according to standard of care and should not be enrolled. * Zubrod/Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 Exclusion Criteria: * Patient cannot undergo MRI without contrast as per standard of care * Patient and family do not speak English or Spanish * Patient receiving treatment with non-curative intent * Patients with an expected 3-year overall survival less than 50%

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Conditions

The condition(s) this trial relates to.

brain cancer brain neoplasm skull base neoplasm

As listed by the trial registrant

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

Brain cancer Brain tumor Skull base tumor

Contacts and locations

Locations

  • Miami Cancer Institute at Baptist Health South Florida

    Miami, Florida, 33176, United States

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