Brain Imaging Changes Following Proton Therapy for Pediatric Primary Central Nervous System and Base of Skull Tumors
- Conditions
- Malignant Central Nervous System NeoplasmMalignant Skull Base Neoplasm
- Interventions
- Other: Medical Chart Review
- Registration Number
- NCT04296617
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
PRIMARY OBJECTIVE:
I. To establish linear energy transfer (LET)-based models as early predictors for white matter changes on magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI) sequences in pediatric patients following proton beam therapy for primary central nervous system (CNS) and base of skull tumors.
OUTLINE:
Patients' medical charts are reviewed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational (medical chart review) Medical Chart Review Patients' medical charts are reviewed.
- Primary Outcome Measures
Name Time Method White matter changes within the central nervous system (CNS) following proton beam therapy using magnetic resonance imaging (MRI) sequences At 18 months 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.
Relative biological effectiveness (RBE) predictions Up to 18 months Will compare concordance over time to evaluate if there is an increase, utilizing repeated measures mixtures models.
White matter changes within the CNS following proton beam therapy using diffusion tensor imaging (DTI) sequences At 18 months The concordance of predicted LET values with radiographic white matter changes will be analyzed utilizing a one sample t-test. We will the compare concordance over time to evaluate if there is an increase, utilizing repeated measures mixtures models.
- Secondary Outcome Measures
Name Time Method White matter changes identified on imaging, and predict concordance Up to 18 months Will be described with both clinical acute and late toxicities following proton beam therapy. Exploratory analyses utilizing tests for association and appropriate regression techniques will be conducted to determine the association of dose volume histogram, LET, RBE, and clinical factors on acute and late toxicities caused by white matter changes.
White matter changes within the CNS following proton beam therapy using DTI and MRI Up to 18 months Will assess the white matter changes within the CNS following proton beam therapy using DTI and MRI and determine concordance with predicted RBE values and biological dose.
Dose-volume effect and predicted LET distribution Up to 18 months Will be correlated. Will evaluate the percent of concordance of isodose volumes with white matter changes utilizing pairwise t-tests and repeated measures mixed models.
Trial Locations
- Locations (1)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States