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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to 3 years from treatment

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

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

Primary study objectives

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

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

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

~320