Clinical Trial Details
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Phase Early Phase IInterventional
Spectroscopic MRI Guided Proton Therapy for Pediatric High-Grade Glioma (RAD4500)
Protocol: IRB00106849NCT: NCT04908709
Overview
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.
Eligibility
| Ages | Up to 21 Years |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Child, Adult |
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.
