Assessment of LET-Based Models and Changes Seen on Brain Imaging in Pediatric Patients Following Proton Therapy for Primary Central Nervous System or Base of Skull Tumors

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04296617
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 53
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Central Nervous System Neoplasm; Malignant Skull Base Neoplasm	Other: Medical Chart Review

Detailed Description

PRIMARY OBJECTIVE:

1. 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jan 21, 2019
• Anticipated Primary Completion Date: Jun 21, 2023
• Anticipated Study Completion Date: Jun 21, 2023

Arms and Interventions

Arm	Intervention/Treatment
Observational (medical chart review) Patients' medical charts are reviewed.	Other: Medical Chart Review; Review of medical chart; Other Names: Chart Review

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 21 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259

Sponsors and Collaborators

• Mayo Clinic
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Tamara Z Vern-Gross, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04296617
• Other Study ID Numbers: MC1777; NCI-2020-01197; 18-002279; MC1777; P30CA015083
• First Posted: Mar 5, 2020
• Last Update Posted: Aug 4, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Skull Base Neoplasms

Study Results

No Results Posted as of Aug 4, 2022