Radiation-induced Toxicity of the Heart

NCT ID: NCT06986291

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 325 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2039-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Diagnostic

Patients with non-small cell lung or esophageal cancer (cohort 1) or with breat cancer (cohort 2)

Group Type: OTHER

Imaging and biomarkers

Intervention Type: DIAGNOSTIC_TEST

MR imaging of the heart, ECG and TTE measurements, blood sample

Interventions

Imaging and biomarkers

MR imaging of the heart, ECG and TTE measurements, blood sample

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients 18 years old or older
• Patient's consent and written consent is available
• Patients with the non-small cell lung cancer or esophageal cancer or breast cancer who have an indication for intended curative radio(chemo)therapy (in the case of breast cancer inclusion of female patients only)

Exclusion Criteria

• Patients who are not capable of giving consent
• Pregnant women
• Patients with contraindications for MRI examinations (pacemakers, defibrillators, neurostimulators, aneurysm clips, cochlear implants, permanent make-up, metal splinters or osseosynthetic implants)
• Patients with insufficient kidney function (glomerular filtration rate (GFR) of less than 30 ml/min)
• Patients with the aforementioned tumour entities for whom a palliative indication exists

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Prof. Esther Troost

Prof. Dr. med. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esther G. C. Troost, Prof. Dr. med. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany

Locations

University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology

Dresden, Germany, Germany

Countries

Germany

Central Contacts

Esther G. C. Troost, Prof. Dr. med. Dr.

Role: CONTACT

esther.troost@uniklinikum-dresden.de

+49 351 458 2238

Facility Contacts

Esther G. C. Troost, Prof. Dr. med. Dr.

Role: primary

str.studien@uniklinikum-dresden.de

+49 351 458 2238

Other Identifiers

STR-CorTox-2024

Identifier Type: -

Identifier Source: org_study_id