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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02199366
• Other study ID #: UFPTI 1419-BR02
• Secondary ID: IRB201800163UFJ
• Status: Active, not recruiting
• Start date: September 2014
• Est. completion date: April 22, 2025

Study information

• Verified date: July 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: April 22, 2025
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Florida Proton Therapy Institute	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Ocala Royal Dames

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with changes in cardiac function.	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	Proportion of patients with serious cardiac side effects.	Includes myocardial infarction, valve disorder, congestive heart failure, and angina.	1 year after completion of radiation therapy
Secondary	Mean quality of life score.	Comparison of baseline and post treatment quality of life questionnaires completed by participants.	1 year after radiation treatment