NCT05717998

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Non-Small Cell Carcinoma
• GastroEsophageal Cancer
• Esophagus Cancer

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo cardiac PET/CT
PROCEDURE	Magnetic Resonance Imaging of the Heart	Undergo CMR
PROCEDURE	Positron Emission Tomography	Undergo cardiac PET/CT

Timeline

• Start date: 2021-04-02
• Primary completion: 2026-06-18
• Completion: 2026-06-18
• First posted: 2023-02-08
• Last updated: 2026-01-02

Locations

1 site across 1 country: United States