Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-01197 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 18-002279 | Other Identifier | Mayo Clinic Institutional Review Board |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (medical chart review) | Patients' medical charts are reviewed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Chart Review | Other | Review of medical chart |
|
| Measure | Description | Time Frame |
|---|---|---|
| White matter changes within the central nervous system (CNS) following proton beam therapy using magnetic resonance imaging (MRI) sequences | 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. | At 18 months |
| White matter changes within the CNS following proton beam therapy using diffusion tensor imaging (DTI) sequences | 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. | At 18 months |
| Relative biological effectiveness (RBE) predictions | Will compare concordance over time to evaluate if there is an increase, utilizing repeated measures mixtures models. | Up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| White matter changes within the CNS following proton beam therapy using DTI and MRI | 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. | Up to 18 months |
| Dose-volume effect and predicted LET distribution |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients who are diagnosed with central nervous system or base of skull malignancies, undergoing proton beam therapy
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tamara Z. Vern-Gross, D.O. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| Up to 18 months |
| White matter changes identified on imaging, and predict concordance | 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. | Up to 18 months |