Malignant Brain GliomaNCT04908709
Spectroscopic MRI Guided Proton Therapy in Assessing Metabolic Change in Pediatric Patients With Brain Tumors
A study testing Magnetic Resonance Spectroscopic Imaging and Proton Therapy in people with Malignant Brain Glioma, run by Emory University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Malignant Brain Glioma
- What is being tested?
- Magnetic Resonance Spectroscopic Imaging and Proton Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Dec 2018to 13 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Emory Proton Therapy Center
Atlanta, Georgia, 30308
Ardith R. DeShay, 404-251-0753, adeshay@emory.edu
Bree R. Eaton, MD
- Not yet recruiting
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, 30322
Christina Lomba, 404-785-4803, christina.lomba@choa.org
Bree R. Eaton
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Hillary Gaines, hillary.gaines@emoryhealthcare.org
Bree R. Eaton, MD
About this study
Official title: Spectroscopic MRI Guided Proton Therapy for Pediatric High-Grade Glioma (RAD4500)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To obtain spectroscopic (s)MRI data from pediatric high grade glioma (HGG) patients before receiving standard of care radiation therapy (RT) and correlate baseline Cho/NAA ratios to recurrence patterns. (Cohort 1, observational) II. To assess the feasibility and safety of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery. (Cohort 2, intervention)
SECONDARY OBJECTIVES:
- To evaluate how Cho/NAA defined radiation target volumes compare to standard of care radiation target volumes in size and resulting radiation delivery to adjacent normal tissue, by creating mock comparison RT plans for each patient.
II. To compare voxel-to-voxel changes in pre-treatment and post-treatment sMRI and evaluate as potential early predictor of tumor response/recurrence.
III. To evaluate sMRI as a tool in identifying pseudoprogression vs. true progression and correlate post-treatment sMRI metabolite ratios with histopathology if collected.
IV. To report patterns of failure in relationship to the RT field (local, marginal, or distant), progression-free survival (PFS) and overall survival (OS) among all patients.
- To report patient reported outcomes of health related quality of life (QOL) during and after proton therapy for pediatric HGG.
VI. To build a longitudinal tracking database including clinical data, imaging, and genomic molecular profiling for pediatric HGG treatment.
OUTLINE:
Patients undergo sMRI prior to radiation therapy, at 1, 4, and 7 months after RT, and at the time of suspected recurrence.
- Conditions
- Malignant Brain Glioma
- Being tested
- Magnetic Resonance Spectroscopic Imaging, Proton Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Spectroscopic ImagingProcedure or surgery
Also called 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS
Undergo sMRI
Proton TherapyDevice
Also called Spectroscopic MRI, Proton Radiation Therapy, sMRI imaging, Magnetic Resonance Spectroscopy
Target volume treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Magnetic Resonance Spectroscopic Imaging; Device: 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. Receives: Procedure: Magnetic Resonance Spectroscopic Imaging; Device: Proton Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From Baseline up to 3 years from treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start20 Dec 2018
- Primary completion13 Oct 2029 (estimated)
- Study completion13 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Brain GliomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Bree Eaton, Emory University
- Investigators
- Bree R Eaton, MD, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908709
- Sponsor's protocol ID
- IRB00106849
- Other IDs
- NCI-2018-02065, IRB00106849, RAD4500-18, P30CA138292
- Status last verified
- Mar 2026
- First submitted
- 20 May 2021
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectroscopic MRI Guided Proton Therapy for Pediatric High-Grade Glioma (RAD4500)
- ClinicalTrials.gov ID
- NCT04908709
- Acronym / sponsor ID
- IRB00106849
- Conditions
- Malignant Brain Glioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 13 Oct 2029 (estimated)
- Study completion
- 13 Oct 2030 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To obtain spectroscopic (s)MRI data from pediatric high grade glioma (HGG) patients before receiving standard of care radiation therapy (RT) and correlate baseline Cho/NAA ratios to recurrence patterns. (Cohort 1, observational) II. To assess the feasibility and safety of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery. (Cohort 2, intervention)
SECONDARY OBJECTIVES:
- To evaluate how Cho/NAA defined radiation target volumes compare to standard of care radiation target volumes in size and resulting radiation delivery to adjacent normal tissue, by creating mock comparison RT plans for each patient.
II. To compare voxel-to-voxel changes in pre-treatment and post-treatment sMRI and evaluate as potential early predictor of tumor response/recurrence.
III. To evaluate sMRI as a tool in identifying pseudoprogression vs. true progression and correlate post-treatment sMRI metabolite ratios with histopathology if collected.
IV. To report patterns of failure in relationship to the RT field (local, marginal, or distant), progression-free survival (PFS) and overall survival (OS) among all patients.
- To report patient reported outcomes of health related quality of life (QOL) during and after proton therapy for pediatric HGG.
VI. To build a longitudinal tracking database including clinical data, imaging, and genomic molecular profiling for pediatric HGG treatment.
OUTLINE:
Patients undergo sMRI prior to radiation therapy, at 1, 4, and 7 months after RT, and at the time of suspected recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (sMRI) | Experimental | Procedure: Magnetic Resonance Spectroscopic Imaging, Device: Proton TherapyPatients undergo sMRI over less than 1 hour within 7 days prior to start of standard of care radiation therapy and at 10 weeks. |
| Group 2 | Active comparator | Procedure: Magnetic Resonance Spectroscopic Imaging, Device: Proton TherapyPatients 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. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Spectroscopic ImagingAlso: 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRSUndergo sMRI | Procedure or surgery | Diagnostic (sMRI), Group 2 |
| Proton TherapyAlso: Spectroscopic MRI, Proton Radiation Therapy, sMRI imaging, Magnetic Resonance SpectroscopyTarget volume treatment | Device | Diagnostic (sMRI), Group 2 |
Primary outcome
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
The spatial relationship between baseline sMRI abnormalities and tumor recurrence will be reported and proportion of overlap will be quantified.
Incidence of adverse events
Time frame: Through 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 delivery
Time frame: From Baseline up to 3 years from treatment
Will be estimated by the Kaplan-Meier Method.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bree R Eaton, MD principal investigator
Emory University Hospital/Winship Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Spectroscopic Imaging and Proton Therapy in people with Malignant Brain Glioma, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bree Eaton, MD (404-778-3473, brupper@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.