Clinical trial · Observational
Brain Imaging Changes Following Proton Therapy for Pediatric Primary Central Nervous System and Base of Skull Tumors
Assessment of Predicted LET and Dosimetry in Relation to White Matter Changes in Pediatric Patients Following Proton Therapy for Primary Central Nervous System and Base of Skull Malignancies: A Pilot Study
- 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 gathers information from patients with primary central nervous system or base of skull tumors that receive proton beam therapy and see if certain imaging techniques can help detect radiation-related changes over time. This study may help providers learn more about proton beam radiotherapy and how to improve the way it is delivered.
Conditions
Conditions (2)
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 Central Nervous System Neoplasm | Malignant Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Malignant Skull Base Neoplasm | Malignant Skull Base Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Medical Chart Review | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (medical chart review)
- description
- Patients' medical charts are reviewed.
- interventionNames
- Other: Medical Chart Review
Primary outcomes (3)
- measure
- White matter changes within the central nervous system (CNS) following proton beam therapy using magnetic resonance imaging (MRI) sequences
- timeFrame
- At 18 months
- description
- The concordance of predicted linear energy transfer linear (LET) values with radiographic white matter changes will be analyzed utilizing a one sample t-test. Will the compare concordance over time to evaluate if there is an increase, utilizing repeated measures mixtures models.
- measure
- White matter changes within the CNS following proton beam therapy using diffusion tensor imaging (DTI) sequences
- timeFrame
- At 18 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically confirmed central nervous system of skull base tumors * Patient is going to undergo central nervous system (CNS) or base of skull proton beam therapy Exclusion Criteria: * Patients who have received prior therapeutic radiotherapy to the primary brain tumor site * Patients who are unable to maintain follow-up through the Phoenix Children's Hospital and Mayo Clinic Arizona
References
Publications (0)
Data not yet available