NCT02688166

Cardiac MRI Biomarker Testing (GCC 1618)

Cardiac Magnetic Resonance Imaging and Biomarker Testing for Evaluating Cardiac Injury Resulting From Radiation Therapy in Cancer: A Pilot Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study can help understand how cardiac changes may occur with radiation therapy to the heart based off measurements obtained through biomarkers and cardiac imaging. Researchers plan to perform cardiac imaging and biomarkers for any cardiac injury. Cardiac magnetic resonance imaging (CMR) provides the ability to quantitatively measure cardiac function and injury. The cardiac biomarkers that will be tested are effective in the diagnosis, risk-stratification, and monitoring of heart failure.

Detailed description

The goal is to assess the validity of CMR and biomarker examinations before and after radiotherapy for lung cancer, thymic cancer, mesothelioma and breast cancers will demonstrate evidence of cardiac strain and dysfunction proportional to the extent of cardiac exposure during the course of radiation. The investigators intention is to conduct a pilot study of 10 patients receiving moderate doses of radiation exposure to the heart (5 lung cancer patients, , thymic cancer or mesothelioma and 5 breast cancer patients) when treated by our current institutional standards with the idea that this could lead to a grant if early signs of cardiac injury can be measured. These patients' treatment plans would include contours to measure dose received by multiple structures within the heart (coronary vessels and all cardiac chambers) as well as the heart/pericardium itself. The investigators would obtain biomarkers by bloodwork before, during, and after radiotherapy for correlation with clinical outcomes and Cardiac MRIs obtained prior to and 1 year after completion of radiotherapy. Investigators would obtain biomarkers by bloodwork before, during, and after radiotherapy for correlation with clinical outcomes and Cardiac MRs obtained prior to and 1 year after completion of radiotherapy.

Conditions

• Breast Cancer
• Lung Cancer (Non-Small Cell)
• Thoracic Cancer
• Thymic Cancer
• Mesothelioma

Interventions

Type	Name	Description
OTHER	Complete Cardiac Magnetic Resonance Imaging (MRI)	Complete Cardiac Magnetic Resonance Imaging (MRI) prior to treatment and then at approximately 1 year after completion of radiation therapy

Timeline

• Start date: 2018-02-01
• Primary completion: 2022-09-09
• Completion: 2022-09-09
• First posted: 2016-02-23
• Last updated: 2022-10-13

Locations

1 site across 1 country: United States