Actively Recruiting

Phase Not Applicable
Age: 1Year - 26Years
All Genders
Healthy Volunteers
NCT05658731

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

Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-07-01

338

Participants Needed

2

Research Sites

654 weeks

Total Duration

On this page

Sponsors

S

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 1Year - 26Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 1 to less than 26 years
  • Tumor located in the brain or adjacent areas including nasopharynx, paranasal sinuses, or orbit
  • Treatment includes radiation therapy (proton or photon)
  • Patients must not have completed radiation therapy
  • Diagnosed with a brain tumor before 26 years of age
  • Received radiation to the brain as part of therapy
  • At least 2 years have passed since radiation start to study enrollment
  • No disease recurrence since most recent radiation treatment
  • Aged 5 to less than 26 years
  • Able to complete research imaging without sedation
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Unable to undergo neurocognitive testing, including lack of English comprehension or premorbid neurological/neurodevelopmental disorders such as Down's syndrome or autism
  • Major psychiatric, neurologic, or medical diagnosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Sibley Memorial Hospital

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

Actively Recruiting

2

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Actively Recruiting

Loading map...

Research Team

S

Sahaja Acharya, MD

CONTACT

K

Katie Lowe

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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