Malignant Central Nervous System Neoplasm, Malignant Skull Base Neoplasm
Conditions
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.
Interventions
OTHERMedical Chart Review
Review of medical chart
Sponsors
Mayo Clinic
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed