About this trial
This trial studies how well spectroscopic magnetic resonance imaging (MRI) guided proton therapy works in assessing metabolic change in pediatric patients with brain tumors. The non-invasive imaging, such as spectroscopic MRI may help to map the differences in tumor metabolism compared to healthy tissue without injection of any contrast agent.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically diagnosed high-grade glioma (World Health Organization [WHO] grade 3-4). Patients with a radiographically diagnosed high-grade glioma may enroll prior to pathologic confirmation, but would be removed from study if pathology did not confirm the diagnosis of high-grade glioma.
Primary tumor located within the supratentorial brain.
Recommended to receive definitive radiation therapy.
Able to receive MRI scans.
Disqualifiers
Patients with pacemakers, non-titanium aneurysm clips, neurostimulators, cochlear implants, non-titanium metal in ocular structures, or other incompatible implants which makes MRI safety an issue are excluded.
Patients that have any significant medical illnesses that in the investigator's opinion cannot be adequately tolerate MRI scan are excluded.
Pathology demonstrated low-grade glioma or other benign or non-invasive brain tumor.
Trial design
Parallel
Treatments tested in this trial
Magnetic Resonance Spectroscopic Imaging
Procedure/SurgeryUndergo sMRI
Proton Therapy
DeviceTarget volume treatment
Treatment groups
Trial outcomes
Primary outcomes
Cho/NAA ratios at baseline in tumor and in regions of tumor recurrence in patients receiving standard of care radiotherapy
The spatial relationship between baseline sMRI abnormalities and tumor recurrence will be reported and proportion of overlap will be quantified.
Incidence of adverse events
Toxicity will be defined according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Feasibility of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery
Will be estimated by the Kaplan-Meier Method.
Sponsors and contacts
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Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator