Brain Imaging Changes Following Proton Therapy for Pediatric Primary Central Nervous System and Base of Skull Tumors

Malignant Central Nervous System Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04296617
• Other study ID #: MC1777
• Secondary ID: NCI-2020-0119718
• Status: Completed
• Start date: January 21, 2019
• Est. completion date: October 23, 2023

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 23, 2023
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Malignant Central Nervous System Neoplasm
• Malignant Skull Base Neoplasm
• Neoplasms
• Nervous System Neoplasms
• Skull Base Neoplasms

Intervention

Other:
• Medical Chart Review
Review of medical chart

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	Dose-volume effect and predicted LET distribution	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
Secondary	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