Image

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

Recruiting
1 - 26 years of age
Both
Phase N/A

Powered by AI

Overview

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.

Eligibility

  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 autism2. STRATUM B
    3. 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
    4. 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 autism3. STRATUM C
    5. Eligibility Criteria
      • must be aged 5 to <26 years of age
      • must be able to complete research imaging without sedation
    6. Exclusion Criteria
      • must not have any major psychiatric, neurologic or medical diagnosis

Study details

Brain Tumor, Head and Neck Cancer

NCT05658731

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

14 June 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.