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

NCT04296617 | Completed

• 3 other identifiers: MC1777NCI-2020-0119718-002279
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Central Nervous System Neoplasm; Malignant Skull Base Neoplasm

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• White matter changes within the CNS following proton beam therapy using DTI and MRI

  Up to 18 months

• Dose-volume effect and predicted LET distribution

  Up to 18 months

• White matter changes identified on imaging, and predict concordance

  Up to 18 months

Study Arms (1)

Observational (medical chart review)

Patients' medical charts are reviewed.

Other: Medical Chart Review

Interventions

Medical Chart Review OTHER

Review of medical chart

Also known as: Chart Review

Observational (medical chart review)

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are diagnosed with central nervous system or base of skull malignancies, undergoing proton beam therapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Central Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Study Officials

• Tamara Z. Vern-Gross, D.O.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 5, 2020
• Study Start: January 21, 2019
• Primary Completion: October 23, 2023
• Study Completion: October 23, 2023
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

US (1)