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Proton Beam Therapy

Proton Beam Radiotherapy for Brain Tumor

N/A

Recruiting

Led By Andrei Holodny, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The patient has been recommended to receive cranial PBRT for a primary or metastatic brain tumor

The patient is between the ages of 6 through 25 at time of consent

Must not have

As per medical record, there is an existing diagnosis of psychiatric disorder or untreated mood disturbance, prior stroke or intracranial hemorrhage, or neurodegenerative disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether proton beam radiation therapy (PBRT) changes resting state brain networks in children and young adults. Researchers will also look at cognitive abilities and quality of life.

Who is the study for?

This trial is for children and young adults aged 6-25 with brain tumors who are undergoing or recommended to receive proton beam radiation therapy (PBRT), can have an MRI without sedation, and take medications as directed. Healthy individuals in the same age range with no major illnesses can also participate as controls.

What is being tested?

The study examines how PBRT affects brain function and quality of life by comparing resting state brain networks, cognitive abilities, and well-being between patients treated with PBRT and healthy participants using rs-fcMRI scans and neurocognitive assessments.

What are the potential side effects?

While this study does not involve drugs that may cause typical side effects, undergoing MRIs might be uncomfortable for some participants. The main focus is on potential changes in brain function due to PBRT rather than immediate side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am advised to undergo proton beam radiation therapy for my brain tumor.

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I am between 6 and 25 years old.

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I have been diagnosed with a brain tumor.

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I have been treated for a brain tumor.

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I am a parent of a child aged 6 to 25.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a psychiatric disorder, mood disturbance, had a stroke or brain bleed, or have a neurodegenerative disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

differences in the resting state brain networks of children and young adults

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: patientsExperimental Treatment2 Interventions

A full neurocognitive battery with quality-of-life assessment will be conducted and an rs-fcMRI sequence will be added to the brain MRI performed as standard of care follow-up between 3-5 months post-PBRT.

Group II: healthy matched controlsExperimental Treatment2 Interventions

Healthy participants will be asked to complete the MRI scan and undergo neurocognitive assessment.

0 / 6Eligibility criteria met