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Completed

NCT Number: NCT02199366

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida Proton Therapy Institute

Jacksonville, Florida, 32206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Cardiac magnetic resonance (cardiac MRI)

Procedure

Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.

Other names: Cardiac MRI, CMR

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Ocala Royal Dames

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2021
Study completion
2025
First posted
Jul 24, 2014
Registry last updated
Jun 11, 2025

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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