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Proton Beam Therapy

Proton Beam Radiotherapy for Brain Tumor

N/A
Recruiting
Led By Behroze Vachha, MD, PhD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
differences in the resting state brain networks of children and young adults

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.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,938 Previous Clinical Trials
588,329 Total Patients Enrolled
Behroze Vachha, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
14 Total Patients Enrolled
Andrei Holodny, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
72 Total Patients Enrolled

Media Library

Proton Beam Radiotherapy (PBRT) (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05288439 — N/A
Brain Tumor Research Study Groups: patients, healthy matched controls
Brain Tumor Clinical Trial 2023: Proton Beam Radiotherapy (PBRT) Highlights & Side Effects. Trial Name: NCT05288439 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limit for enrolment in this trial extend beyond 80 years?

"The qualifications for this research trial demand that potential participants are between 6 and 21 years of age. According to the data, there are 347 studies targeting people younger than 18 and 2498 related to seniors above 65."

Answered by AI

What is the uppermost cap on participants in this investigation?

"Indeed, the clinical trial is still recruiting. The date of inception was 3/7/2022 and it has been updated as recently as 9/21/2022. Aspiring participants should note that this study requires 40 volunteers from a single centre."

Answered by AI

Are physicians currently enlisting volunteers for this research effort?

"As evidenced by the details on clinicaltrials.gov, this research project is currently recruiting participants. The initial posting was made on March 7th 2022 and it was most recently revised on September 21st of the same year."

Answered by AI

Who has the eligibility to join this medical experiment?

"This trial seeks to enroll 40 children between 6 and 21 years old with a primary or metastatic brain tumor. For entry, affected patients must be able to tolerate MRI imaging without sedation as per their medical record or patient report, while healthy controls must meet the same requirement according to parental reports. All applicants are required to only take medications prescribed by their physician; avoiding agents that may influence the central nervous system such as benzodiazepines and antihistamines is highly recommended on days of imaging/neurocognitive assessment."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of How Proton Beam Radiotherapy (PBRT) Affects Brain Function and Quality of Life in Children and Young Adults Undergoing Treatment for a Brain Tumor
2022. "A Study of How Proton Beam Radiotherapy (PBRT) Affects Brain Function and Quality of Life in Children and Young Adults Undergoing Treatment for a Brain Tumor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05288439.
All > Brain Tumor
~10 spots leftby Mar 2025
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