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Spots Global Cancer Trial Database for Imaging and Blood-Based Biomarkers for the Evaluation of Early Signs of Myocardial Injury After Thoracic Radiation Therapy

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Trial Identification

Brief Title: Imaging and Blood-Based Biomarkers for the Evaluation of Early Signs of Myocardial Injury After Thoracic Radiation Therapy

Official Title: A Pilot Study to Evaluate Early Signs of Myocardial Injury After Thoracic Radiotherapy Using Imaging and Blood-Based Biomarkers

Study ID: NCT05717998

Study Description

Brief Summary: This study assesses for early signs of damage to the heart following chest radiation therapy using both imaging (cardiac magnetic resonance imaging and cardiac positron emission tomography) and changes in blood biomarkers. This study determines if any changes in the heart muscle can be detected either during the course of radiation therapy or shortly thereafter using specialized imaging techniques or blood tests. Cardiac magnetic resonance imaging may be used to help provide information about changes in the heart structure and function following radiation therapy. Positron emission tomography looks at differences in how the heart takes up radioactive sugar which is injected into the vein to assess changes in heart function following radiation therapy. This study may help identify patients at risk of heart issues following radiation therapy to the chest and ultimately help in the development of more effective and safe treatments for cancer in the future.

Detailed Description: PRIMARY OBJECTIVES: I. To evaluate and quantitate early changes in myocardial fibrosis following thoracic radiation therapy (RT). II. To assess quantitative early changes in myocardial inflammation after thoracic RT. III. To determine if thoracic RT is associated with early changes in myocardial metabolism as assessed with cardiac positron emission tomography (PET). SECONDARY OBJECTIVES: I. To evaluate and quantitate early changes in subclinical myocardial dysfunction after thoracic RT. II. To determine if thoracic RT is associated with early changes in myocardial metabolism using alternative cardiac PET-derived biomarkers. III. To evaluate and quantitate early changes in blood-based biomarkers after thoracic RT. IV. To assess the incidence and severity of cardiac events following completion of thoracic RT. OUTLINE: Within 2 weeks of starting RT, patients undergo cardiac magnetic resonance (CMR) imaging, cardiac positron emission tomography (PET)/computed tomography (CT) and blood sample collection at baseline, then between fractions 12-17 of RT and at 6 months after completion of RT.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Contact Details

Name: Eric D Miller, MD, PhD

Affiliation: Ohio State University Comprehensive Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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