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Completed

NCT Number: NCT04296617

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

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.

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Key information

Conditions

Malignant Central Nervous System Neoplasm Central Nervous System Neoplasms Malignant Skull Base Neoplasm Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

medical chart review

Other

Review of medical chart

Other names: Chart Review

Primary outcomes

  1. White matter changes within the central nervous system (CNS) following proton beam therapy using magnetic resonance imaging (MRI) sequences

    Time frame: 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

    Time frame: 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

    Time frame: Up to 18 months

    Will compare concordance over time to evaluate if there is an increase, utilizing repeated measures mixtures models.

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 5, 2020
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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