Serial Cardiac Magnetic Resonance Imaging (CMR) With Contrast Agents and Biomarker Analysis for the Detection of Cardiotoxicity Under Anthracycline-containing Cancer Therapy
Serial Cardiac Magnetic Resonance Imaging (CMR) With Contrast Agents and Biomarker Analysis for the Detection of Cardiotoxicity Under Anthracycline-containing Cancer Therapy - A Monocentric, Low Interventional Phase IV Pilot Study
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
93 participants
Mar 4, 2026
INTERVENTIONAL
Conditions
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 Criteria1
- \- Patients with a recommendation for antineoplastic therapy including at least four administrations of an anthracycline
Exclusion Criteria23
- 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)
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Interventions
CMR is performed on a 1.5T Siemens Magnetom Aera. The examination follows clinically established protocols for assessing cardiac morphology and function using HASTE and CINE-SSFP sequences. CINE and late gadolinium enhancement (LGE) images of the short axis are taken every 10 mm from the base of the heart to the apex (6 mm slice, resolution 1.2 × 1.8 mm). LGE images are acquired 5-10 minutes after administration of gadolinium. T1 mapping is performed using a MOLLI sequence before and 20 minutes after contrast agent administration, T2 mapping using an ECG-triggered T2-prepared SSFP sequence before contrast agent administration. The evaluation is performed independently by two examiners with manual marking of endocardial and epicardial boundaries. Left ventricular volumes and ejection fraction are calculated using the summation method, and LGE is visually quantified and classified. In addition, T1, ECV, and T2 maps are created from motion-corrected images and global values are calculated
As part of the study, additional biomaterial (blood, urine, stool) will be collected at defined time points. A study-specific biobank will be created. Blood samples will be taken at baseline, mid-point analysis, and 3 and 12 months after the end of therapy. The methods used will analyze the DNA, RNA, and protein levels of the stored tissue material and perform functional tests. Genetic variants will be detected using established methods such as real-time PCR methods, mass spectrometric detection or nanofluid technology, as well as DNA microarrays or genome sequencing. Endogenous metabolites or metabolite profiles as well as drug concentrations and their metabolites can be detected in blood, urine, and, if necessary, stool using various mass spectrometric methods as well as biochemical assays. The cytokine profile can be analyzed in plasma isolated from blood samples. Proinflammatory cytokines in doxorubicin-induced cardiotoxicity have been described and should therefore be determined.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07528586