Study Summary
This trial studies how well spectroscopic MRI guided proton therapy works in assessing metabolic change in pediatric patients with brain tumors.
Eligible Conditions
- Brain Tumor
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 0 Secondary · Reporting Duration: From Baseline up to 3 years from treatment
Year 3
Feasibility of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery
Year 1
Cho/NAA ratios at baseline in tumor and in regions of tumor recurrence in patients receiving standard of care radiotherapy
Incidence of adverse events
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Group 2
1 of 2
Diagnostic (sMRI)
1 of 2
Active Control
Experimental Treatment
25 Total Participants · 2 Treatment Groups
Primary Treatment: Magnetic Resonance Spectroscopic Imaging · No Placebo Group · N/A
Diagnostic (sMRI)Experimental Group · 2 Interventions: Magnetic Resonance Spectroscopic Imaging, Proton Therapy · Intervention Types: Procedure, Device
Group 2ActiveComparator Group · 2 Interventions: Magnetic Resonance Spectroscopic Imaging, Proton Therapy · Intervention Types: Procedure, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Spectroscopic Imaging
2012
N/A
~290
Proton Therapy
2009
Completed Phase 2
~280
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline up to 3 years from treatment
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,071 Previous Clinical Trials
41,128,828 Total Patients Enrolled
Emory UniversityLead Sponsor
1,509 Previous Clinical Trials
2,706,144 Total Patients Enrolled
Bree R Eaton, MDPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute
Eligibility Criteria
Age < 65 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Patients with a radiographically diagnosed tumor that is High Grade Glioma (WHO grade 3-4) may enroll prior to pathology confirmation, but would be removed from study if pathology did not confirm the diagnosis of High Grade Glioma.
The tumor is located in the upper part of the brain.
The text recommends that the person receive radiation therapy, which is a definitive treatment.
Capable of acquiring MRI scans.
This trial is open to males and females of all races and ethnic groups.
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Conditions
Cancer Related
Treatments