Biomarkers and Cardiac MRI as Early Indicators of Cardiac Exposure Following Breast Radiotherapy

CompletedOBSERVATIONAL
Enrollment

25

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

December 31, 2017

Study Completion Date

December 31, 2018

Conditions
Breast Cancer
Interventions
PROCEDURE

Research Cardiac MRI

Cardiac MRI has increased use in evaluating structural and functional cardiac pathologies. For detection of coronary artery disease, MRI outperforms SPECT and dobutamine stress echocardiography for the detection of ischemia. MRI also can detect wall-motion abnormalities and other dysfunction. Dynamic contrast-enhanced MRI (DCE-MRI) can evaluate microvascular parameters such as vessel permeability and fluid volume fraction as an assessment of tissue perfusion. Cardiac MRI holds promise for early detection of subclinical cardiac abnormalities after radiotherapy and could potentially identify patients for intervention to prevent cardiac events. All patients will follow the protocol calendar requiring research MRIs, but will receive standard radiation treatment determined by their physician. Treatment will not be altered based on MRI.

PROCEDURE

Biomarkers

"We have identified potential candidates based on other processes affecting heart function in a way similar to probable mechanisms of RT-related injury. For fibrosis and left ventricular dysfunction, these include galectin-3 and N-terminal-Pro brain natriuretic peptide. For myocyte destruction, troponin; for inflammation and oxidative stress, C-reactive protein, myeloperoxidase, and growth differentiation factor 15. Additional blood will be collected and stored for future assessment of other candidate biomarkers.~All patients will follow the calendar of protocol required research blood draws for biomarker collection, but will receive standard radiation treatment as clinically indicated by their physician. Treatment will not be altered based upon the data collected from these samples."

Trial Locations (1)

48202

Henry Ford Health System, Detroit

All Listed Sponsors
collaborator

University of Michigan Rogel Cancer Center

OTHER

lead

Henry Ford Health System

OTHER

NCT02496260 - Biomarkers and Cardiac MRI as Early Indicators of Cardiac Exposure Following Breast Radiotherapy | Biotech Hunter | Biotech Hunter