Using MRI to guide proton therapy for pediatric brain tumors
Spectroscopic MRI Guided Proton Therapy for Pediatric High-Grade Glioma (RAD4500)
This study is testing whether using special MRI scans can help doctors better target proton therapy for children with brain tumors to improve their treatment outcomes and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | N/A to 21 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Atlanta, Georgia and 2 other locations) |
| Trial ID | NCT04908709 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of spectroscopic magnetic resonance imaging (sMRI) in guiding proton therapy for pediatric patients with malignant brain gliomas. It aims to assess metabolic changes in tumors compared to healthy tissue without the need for contrast agents. The study includes two cohorts: one observational to collect baseline data and another to evaluate the feasibility and safety of using sMRI for defining radiation target volumes. Additionally, it seeks to correlate imaging findings with treatment outcomes and quality of life measures.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients diagnosed with high-grade gliomas who are recommended for radiation therapy.
Not a fit: Patients with low-grade gliomas or those with incompatible medical implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment precision and outcomes for children with brain tumors.
How similar studies have performed: While the use of MRI in treatment planning is established, the specific application of sMRI in guiding proton therapy for pediatric gliomas is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Atlanta, Georgia and 2 other locations
- Emory Proton Therapy Center — Atlanta, Georgia, United States (Recruiting)
- Children's Healthcare of Atlanta - Scottish Rite — Atlanta, Georgia, United States (Not_yet_recruiting)
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Bree R Eaton, MD — Emory University Hospital/Winship Cancer Institute
- Study coordinator: Bree Eaton, MD
- Email: brupper@emory.edu
- Phone: 404-778-3473
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.