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Proton Beam Therapy

Proton Therapy for Pediatric Brain Cancer

N/A
Recruiting
Led By Bree R Eaton, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary tumor located within the supratentorial brain
Be younger than 65 years old
Must not have
Pathology demonstrated low-grade glioma or other benign or non-invasive brain tumor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 3 years from treatment
Awards & highlights

Summary

This trial studies how well spectroscopic MRI guided proton therapy works in assessing metabolic change in pediatric patients with brain tumors.

Who is the study for?
This trial is for children with high-grade brain tumors (WHO grade 3-4) who are recommended to receive radiation therapy and can undergo MRI scans. It's open to all genders, races, and ethnic groups. The tumor must be in the upper part of the brain. Kids with significant illnesses that make MRI unsafe or have certain implants like pacemakers are not eligible.Check my eligibility
What is being tested?
The study is testing how well a special type of MRI called spectroscopic imaging works alongside proton therapy to see changes in the metabolism of brain tumors in kids without using contrast agents. This non-invasive method could help distinguish between healthy tissue and tumor metabolism.See study design
What are the potential side effects?
Since this trial focuses on assessing metabolic change through imaging rather than treatment effects, side effects may primarily relate to discomfort or risks associated with undergoing MRIs, such as anxiety in closed spaces or reactions if sedation is needed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My brain tumor is located above the cerebellum.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My brain tumor is non-cancerous and low-grade.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 3 years from treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 3 years from treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cho/NAA ratios at baseline in tumor and in regions of tumor recurrence in patients receiving standard of care radiotherapy
Feasibility of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery
Incidence of adverse events

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Diagnostic (sMRI)Experimental Treatment2 Interventions
Patients undergo sMRI over less than 1 hour within 7 days prior to start of standard of care radiation therapy and at 10 weeks.
Group II: Group 2Active Control2 Interventions
Patients will undergo 3-4 sMRI scans at baseline prior to RT, 1 month, 4 months, and 7 months after RT, and/or at any time of suspected tumor recurrence.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Spectroscopic Imaging
2012
Completed Phase 1
~430
Proton Therapy
2013
Completed Phase 2
~340

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,655 Previous Clinical Trials
2,572,458 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,376 Total Patients Enrolled
Bree R Eaton, MDPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute

Media Library

Proton Therapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04908709 — N/A
Brain Tumor Research Study Groups: Diagnostic (sMRI), Group 2
Brain Tumor Clinical Trial 2023: Proton Therapy Highlights & Side Effects. Trial Name: NCT04908709 — N/A
Proton Therapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04908709 — N/A
~1 spots leftby Oct 2024
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