Recruiting

Proton Therapy

Sponsor:

Emory University

Code:

NCT04908709

Conditions

Malignant Brain Glioma

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Magnetic Resonance Spectroscopic Imaging

Proton Therapy

Study Details

Brief summary:

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.

Conditions

Malignant Brain Glioma

Study ID

NCT04908709

Start date

Dec 20, 2018

Status verified date

Mar, 2026

Completion date

Oct 13, 2030

Anticipated

Primary completion date

Oct 13, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Diagnostic (sMRI)

Patients undergo sMRI over less than 1 hour within 7 days prior to start of standard of care radiation therapy and at 10 weeks.

active comparator: Group 2

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.

Interventions

Magnetic Resonance Spectroscopic Imaging

Undergo sMRI

Proton Therapy

Target volume treatment

Primary outcome measure

  • Cho/NAA ratios at baseline in tumor and in regions of tumor recurrence in patients receiving standard of care radiotherapy [ Time Frame: Through study completion, an average of 1 year ]
  • Incidence of adverse events [ Time Frame: Through study completion, an average of 1 year ]
  • Feasibility of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery [ Time Frame: From Baseline up to 3 years from treatment ]

Central Contacts and Locations

Central contacts

Bree Eaton, MD

404-778-3473brupper@emory.edu

Locations

Emory Proton Therapy Center

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Ardith R. DeShay

404-251-0753adeshay@emory.edu

Principal Investigator:

Bree R. Eaton, MD

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Hillary Gaines

hillary.gaines@emoryhealthcare.org

Principal Investigator:

Bree R. Eaton, MD

More Information

Sponsor

Emory University

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-03-04.