NCT04908709

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
54mo left

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Dec 2018Oct 2030

Study Start

First participant enrolled

December 20, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2030

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

10.8 years

First QC Date

May 20, 2021

Last Update Submit

March 2, 2026

Conditions

Malignant Brain Glioma

Outcome Measures

Primary Outcomes (3)

  • 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.

    Through study completion, an average of 1 year

  • Incidence of adverse events

    Toxicity will be defined according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Through study completion, an average of 1 year

  • Feasibility of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery

    Will be estimated by the Kaplan-Meier Method.

    From Baseline up to 3 years from treatment

Study Arms (2)

Diagnostic (sMRI)

EXPERIMENTAL

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

Procedure: Magnetic Resonance Spectroscopic ImagingDevice: Proton Therapy

Group 2

ACTIVE COMPARATOR

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.

Procedure: Magnetic Resonance Spectroscopic ImagingDevice: Proton Therapy

Interventions

Proton TherapyDEVICE

Target volume treatment

Also known as: Spectroscopic MRI, Proton Radiation Therapy, sMRI imaging, Magnetic Resonance Spectroscopy, 3D whole brain MR spectroscopic imaging sequence
Diagnostic (sMRI)Group 2
Magnetic Resonance Spectroscopic ImagingPROCEDURE

Undergo sMRI

Also known as: 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS, MRS Imaging, MRSI, Proton Magnetic Resonance Spectroscopic Imaging
Diagnostic (sMRI)Group 2

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Emory Proton Therapy Center

Atlanta, Georgia, 30308, United States

RECRUITING

Children's Healthcare of Atlanta - Scottish Rite

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance SpectroscopyProton Therapy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesHeavy Ion RadiotherapyRadiotherapyTherapeutics

Study Officials

  • Bree R Eaton, MD

    Emory University Hospital/Winship Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bree Eaton, MD

CONTACT

404-778-3473brupper@emory.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2021

First Posted

June 1, 2021

Study Start

December 20, 2018

Primary Completion (Estimated)

October 13, 2029

Study Completion (Estimated)

October 13, 2030

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

US(3)