Serial Cardiac Magnetic Resonance Imaging (CMR) With Contrast Agents and Biomarker Analysis for the Detection of Cardiotoxicity Under Anthracycline-containing Cancer Therapy
NCT07528586
Summary
The goal of the trial is the early detection of cardiotoxicity in patients treated with anthracycline-based chemotherapy. Current diagnostics, such as troponin T, NT-pro-BNP, electrocardiogram, and echocardiography, are not able to identify early myocardial damage. Therefore, this study aims to identify early myocardial damage by using cardiac magnetic resonance imaging. The primary endpoint of this study is the change in relaxation times in CMR before, during, and after therapy. Furthermore, the study analyzes: * other abnormal results in CMR * changes in troponin T and NT-pro-BNP * changes in global longitudinal strain in echocardiography and correlation with results of CMR * detection of new biomarkers in blood, urine, or stool
Eligibility
Inclusion Criteria \- Patients with a recommendation for antineoplastic therapy including at least four administrations of an anthracycline Exclusion Criteria * Inability to provide informed consent * Prior administration of an anthracycline * Administration of cardiotoxic drugs within the last six months, such as: * High-dose cyclophosphamide (\>1,000 mg/m² or \>10 mg/kg) * HER2 inhibitors * VEGF inhibitors * BCR-ABL inhibitors * BRAF inhibitors * MEK inhibitors * Immune checkpoint inhibitors (CTLA-4 inhibitors, PD-1 inhibitors, PD-L1 inhibitors) * Planned invasive cardiac intervention during the study period * Cardiac involvement of an underlying disease, e.g. amyloidosis * Treatment with fewer than four administrations of anthracyclines * Treatment with a liposomal anthracycline formulation * Treatment in which anthracyclines are not administered in every chemotherapy cycle * Thoracic radiation involving the heart prior to anthracycline administration * Participation in another clinical study concurrently or within the last three months * Renal impairment with a GFR \< 30 ml/min/1.73 m² * Patients in the perioperative phase of liver transplantation * Contraindications to cardiac magnetic resonance imaging, such as metallic implants (e.g. cardiac pacemaker) * Pregnancy or breastfeeding * Hypersensitivity or intolerance to gadolinium-based contrast agents * Vulnerable populations (individuals unable to protect their own interests, prisoners)
Conditions4
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NCT07528586