NCT06986291

Radiation-induced Toxicity of the Heart

Quantitative Assessment of Radiation-induced Toxicity of the Heart

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 325 (estimated)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Late side effects in radio(chemo)therapy \[R(CH)T\] pose a critical limitation to patients' overall survival and quality of life. Even though toxicities of the heart are highly relevant for patients with cancer in the thoracic region, risk stratification models for these toxicities are lacking. In this study, liquid, functional and imaging biomarkers are being investigated for their use in prediction of cardiac toxicity following R(CH)T for patients with thoracic malignancies.

Detailed description

79 patients with non-small cell lung or esophageal cancer, and 246 patients with breast cancer to be treated with curative R(CH)T at the University Hospital Carl Gustav Carus Dresden, Germany will be included in this investigation. Dosimetric parameters from the applied radiation treatment plans, magnetic-resonance-imaging, electrocardiography, transthoracic echocardiography as well as blood-biomarkers will be collected to determine their predictive power against the primary endpoint of cumulative grade ≥ 2 cardio-toxicity (Common Terminology Criteria for Adverse Events \[CTCAE\] v 5.0) 3-5 years after R(CH)T.

Conditions

• Non-small Cell Lung Cancer
• Esophageal Cancer
• Breast Cancer Female

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Imaging and biomarkers	MR imaging of the heart, ECG and TTE measurements, blood sample

Timeline

• Start date: 2025-08-01
• Primary completion: 2034-12-01
• Completion: 2039-12-01
• First posted: 2025-05-23
• Last updated: 2025-05-29

Locations

1 site across 1 country: Germany