Clinical trial NCT06986291: Radiation-induced Toxicity of the Heart
Official title: Quantitative Assessment of Radiation-induced Toxicity of the Heart
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-small Cell Lung Cancer
Esophageal Cancer
Breast Cancer Female
Keywords: Non-small cell lung cancer
Esophageal cancer
Breast cancer
Cardiotoxicity
Radio(chemo)therapy
MRI
Cardiac function test
Omics analyses
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: There are two cohorts (patients with non-small cell lung or esophageal cancer; patients with breast cancer) but receiving the same intervention.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cumulative cardio-toxicity after 1 or 5 years
timeFrame: 12 or 60 months after end of treatment
Secondary outcomes:
measure: Cumulative cardio-toxicity (early and late)
timeFrame: 3 months as well as 2, 3, 4, 5 and 10 years after end of treatment
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology
Study officials:
affiliation: Department of Radiotherapy and Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany
name: Esther G. C. Troost, Prof. Dr. med. Dr.
role: PRINCIPAL_INVESTIGATOR
References: