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

NCT ID: NCT04296617

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-21

Study Completion Date

2023-10-23

Brief Summary

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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

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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.

Conditions

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Malignant Central Nervous System Neoplasm Malignant Skull Base Neoplasm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (medical chart review)

Patients' medical charts are reviewed.

Medical Chart Review

Intervention Type OTHER

Review of medical chart

Interventions

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Medical Chart Review

Review of medical chart

Intervention Type OTHER

Other Intervention Names

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Chart Review

Eligibility Criteria

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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
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tamara Z. Vern-Gross, D.O.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2020-01197

Identifier Type: REGISTRY

Identifier Source: secondary_id

18-002279

Identifier Type: OTHER

Identifier Source: secondary_id

MC1777

Identifier Type: -

Identifier Source: org_study_id

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