Clinical trial · Interventional
Spectroscopic MRI Guided Proton Therapy in Assessing Metabolic Change in Pediatric Patients With Brain Tumors
Spectroscopic MRI Guided Proton Therapy for Pediatric High-Grade Glioma (RAD4500)
NCT04908709CI-TRIAL-00104545recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Brain Glioma | Malignant Brain Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Resonance Spectroscopic Imaging | Procedure | — | UNRESOLVED |
| Proton Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Diagnostic (sMRI)
- description
- Patients undergo sMRI over less than 1 hour within 7 days prior to start of standard of care radiation therapy and at 10 weeks.
- interventionNames
- Procedure: Magnetic Resonance Spectroscopic Imaging
- Device: Proton Therapy
- type
- ACTIVE_COMPARATOR
- label
- Group 2
- description
- 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.
- interventionNames
- Procedure: Magnetic Resonance Spectroscopic Imaging
- Device: Proton Therapy
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.