Study of Cardiac MRI in Patients With Left-Sided Breast Cancer Receiving Radiation Therapy

Overview

This is a pilot study to determine if there are changes in heart function following completion of radiation therapy for breast cancer as measured by cardiac magnetic resonance imaging (cardiac MRI) scans. Additional purposes of this study are to assess cardiac side effects from radiation treatment, evaluate cardiac MRI changes by radiation technique, and compare quality of life questionnaires.

Full Title of Study: “Prospective Pilot Study of Early Markers of Radiation-Induced Cardiac Injury in Patients With Left-Sided Breast Cancer Receiving Photon or Proton Therapy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 7, 2021

Detailed Description

As part of this study, participants will have a cardiac MRI at baseline and a follow-up cardiac MRI within 1 year after completion of standard radiation therapy for left-sided breast cancer. The cardiac MRI scans will be evaluated to determine if there are changes in cardiac function within 1 year after radiation treatment. Patients will be asked to complete a questionnaire before and after treatment that asks about their health and any symptoms they may be having. Physical exams and any other standard of care service or treatment will be at the discretion of the treating physician.

Interventions

  • Procedure: Cardiac magnetic resonance (cardiac MRI)
    • Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.

Arms, Groups and Cohorts

  • Cardiac magnetic resonance (cardiac MRI)
    • Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of participants with changes in cardiac function.
    • Time Frame: 1 year after completion of radiation therapy
    • A change in cardiac function may include shifts from baseline measures of LV mass, strain, ejection fraction, and late gadolinium enhancement.

Secondary Measures

  • Proportion of patients with serious cardiac side effects.
    • Time Frame: 1 year after completion of radiation therapy
    • Includes myocardial infarction, valve disorder, congestive heart failure, and angina.
  • Mean quality of life score.
    • Time Frame: 1 year after radiation treatment
    • Comparison of baseline and post treatment quality of life questionnaires completed by participants.

Participating in This Clinical Trial

Inclusion Criteria

  • Left-sided breast cancer stage I-III. – Indications for adjuvant regional nodal and breast or chest wall radiation therapy (RT). – Women and men are allowed. – Must be at least 18 years old at time of consent. Exclusion Criteria:

  • Pregnant and/or breastfeeding women or patients of child-producing potential not willing to use contraception while on study. – Prior history of cardiovascular disease per physician discretion. – Stage 0 and IV breast cancer. – Prior radiation therapy to chest. – Concurrent trastuzumab per physician discretion.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Florida
  • Collaborator
    • Ocala Royal Dames
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Julie A Bradley, MD, Principal Investigator, University of Florida Proton Therapy Institute

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