Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04296617
Other study ID # MC1777
Secondary ID NCI-2020-0119718
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03565367 - Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors Phase 1
Recruiting NCT00991094 - Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy
Completed NCT04456140 - Pro-Active Genetic Testing in Patients With Solid Tumors, Inherit Study Phase 1
Not yet recruiting NCT05720624 - Pharmacodynamic Analyses of Metabolic Agents Following Brain Radiation Phase 1
Recruiting NCT06117930 - Study of Human Brain-Gut Axis and Gut Microbiome in Patients With Brain Lesions - Repository for Neuroscience Research
Active, not recruiting NCT04217694 - Memantine for the Reduction of Cognitive Impairment After Radiation Therapy in Pediatric Patients With Central Nervous System Tumors Early Phase 1
Completed NCT04276194 - Vertebral Body Sparing Craniospinal Irradiation for Pediatric Patients With Cancer of the Central Nervous System N/A

External Links