Radiation-induced Toxicity of the Heart
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTechnische Universität Dresden
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Imaging and biomarkers
Diagnostic testMR imaging of the heart, ECG and TTE measurements, blood sample
Treatment groups
325 Participants
are divided into 1 treatment groupGroup A: DiagnosticOther 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative cardio-toxicity after 1 or 5 years
Cumulative grade ≥ 2 cardio-toxicity (Common Terminology Criteria for Adverse Events \[CTCAE\] v 5.0) 1 years after R(CH)T in patients with non-small cell lung or esophageal cancer or 5 years after R(CH)T in patients with breast cancer
Time frame
12 or 60 months after end of treatmentSecondary outcomes
1
Cumulative cardio-toxicity (early and late)
Cumulative grade ≥ 2 cardio-toxicity (Common Terminology Criteria for Adverse Events \[CTCAE\] v 5.0) 3 months as well as 2, 3, 4 or 5 years after R(CH)T and in addition 10 years after R(CH)T in patients with breast cancer only.
Time frame
3 months as well as 2, 3, 4, 5 and 10 years after end of treatmentSponsors and contacts
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Source ClinicalTrials.gov
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