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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Florida
Sponsor:
Collaborator:
Ocala Royal Dames
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02199366
First received: July 22, 2014
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Procedure: Cardiac magnetic resonance (cardiac MRI)
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Pilot Study of Early Markers of Radiation-Induced Cardiac Injury in Patients With Left-Sided Breast Cancer Receiving Photon or Proton Therapy

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Proportion of participants with changes in cardiac function. [ Time Frame: 1 year after completion of radiation therapy ] [ Designated as safety issue: No ]
    A change in cardiac function may include shifts from baseline measures of LV mass, strain, ejection fraction, and late gadolinium enhancement.


Secondary Outcome Measures:
  • Proportion of patients with serious cardiac side effects. [ Time Frame: 1 year after completion of radiation therapy ] [ Designated as safety issue: No ]
    Includes myocardial infarction, valve disorder, congestive heart failure, and angina.

  • Mean quality of life score. [ Time Frame: 1 year after radiation treatment ] [ Designated as safety issue: No ]
    Comparison of baseline and post treatment quality of life questionnaires completed by participants.


Estimated Enrollment: 16
Study Start Date: September 2014
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:
  • Cardiac MRI
  • CMR

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Radiation oncology clinic

Criteria

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.
  • Contraindications to cardiac MRI (e.g., contrast reaction, metal implants, etc.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02199366

Contacts
Contact: Intake Coordinator 877-686-6009

Locations
United States, Florida
University of Florida Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Intake Coordinator    877-686-6009      
Principal Investigator: Julie A Bradley, MD         
Sponsors and Collaborators
University of Florida
Ocala Royal Dames
Investigators
Principal Investigator: Julie A Bradley, MD University of Florida Proton Therapy Institute
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02199366     History of Changes
Other Study ID Numbers: UFPTI 1419-BR02
Study First Received: July 22, 2014
Last Updated: October 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Cardiac MRI
Radiation
Proton Radiation
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014