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

July 26, 2023 updated by: University of Florida

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32206
        • University of Florida Proton Therapy Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Radiation oncology clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiac magnetic resonance (cardiac MRI)
Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.
Procedure: Cardiac magnetic resonance (cardiac MRI)
Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.
Other Names:
  • CMR
  • Cardiac MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year after completion of radiation therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year after completion of radiation therapy
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.
1 year after radiation treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

Ocala Royal Dames

Investigators

  • Principal Investigator: Julie A Bradley, MD, University of Florida Proton Therapy Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

July 7, 2021

Study Completion (Estimated)

April 22, 2025

Study Registration Dates

First Submitted

July 22, 2014

First Submitted That Met QC Criteria

July 22, 2014

First Posted (Estimated)

July 24, 2014

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFPTI 1419-BR02
  • IRB201800163 (Other Identifier: UF IRB)
  • UFJ 2014-116 (Other Identifier: UF IRB Old Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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