Spectroscopic MRI Guided Proton Therapy for Pediatric Brain Tumors

This study is looking at how well spectroscopic magnetic resonance imaging (sMRI) guided proton therapy works in children and young adults (up to 21 years old) with high-grade brain tumors. Spectroscopic MRI is a special type of MRI that can show differences in how tumors use energy compared to healthy brain tissue, without needing an injection. The study aims to see if using sMRI can help doctors better plan proton therapy, which is a type of radiation treatment. Researchers will compare sMRI results with how tumors respond to treatment and look for any side effects. The goal is to improve how these brain tumors are treated.

Study design
This study plans to enroll 25 participants. It is an interventional study, meaning participants will receive a specific treatment or procedure.
What's involved
Participants will undergo sMRI and receive proton therapy. The study will track changes and side effects for about one year, and feasibility of using sMRI will be assessed for up to three years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through study completion, which is an average of one year for some endpoints, and up to three years for others.

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NCT04908709

Spectroscopic MRI Guided Proton Therapy in Assessing Metabolic Change in Pediatric Patients With Brain Tumors

Recruiting
NAUp to 21InterventionalTreatment
Emory University
~25 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:Magnetic Resonance Spectroscopic ImagingProton Therapy

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cho/NAA ratios at baseline in tumor and in regions of tumor recurrence in patients receiving standard of care radiotherapy
Measured over Through study completion, an average of 1 year
+2 more outcomes measured
Malignant Brain Glioma
3 sites across 1 states
Georgia3
  • Bree R Eaton, MD · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute

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Eligibility criteria

Inclusion

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.
Both males and females, and members of all races and ethnic groups are eligible for this trial.

Exclusion

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.
  • Cho/NAA ratios at baseline in tumor and in regions of tumor recurrence in patients receiving standard of care radiotherapyThrough study completion, an average of 1 year

    The spatial relationship between baseline sMRI abnormalities and tumor recurrence will be reported and proportion of overlap will be quantified.

  • Incidence of adverse eventsThrough study completion, an average of 1 year

    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 deliveryFrom Baseline up to 3 years from treatment

    Will be estimated by the Kaplan-Meier Method.