Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anthracycline-induced Cardiotoxicity | — | UNRESOLVED | — |
| Cardiotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biosampling for scientific research in study-specific biobank | Other | — | UNRESOLVED |
| CMR based measurement of cardiotoxicity | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Serial cardiac magnetic resonance imaging (CMR)
- description
- In this study, cardiac magnetic resonance imaging (CMR) is used as the primary tool for detecting possible anthracycline-induced cardiotoxicity without affecting standard oncological therapy. Before starting anthracycline-based therapy, a baseline CMR is performed, supplemented by echocardiography (TTE), ECG, and biomarker determination. Further CMR examinations are performed for mid-point analysis after half of the planned chemotherapy cycles, as well as 12-14 weeks and 12 months after the end of therapy. The timing depends on the individual chemotherapy regimen, with CMR scheduled on the same day always taking place before anthracycline administration. The CMR examinations are used for structural and functional assessment of the heart and are combined with other diagnostic procedures (TTE, ECG, biomarkers, biosampling) to detect early changes in heart function and systematically monitor the course of potential cardiotoxic effects during therapy.
- interventionNames
- Diagnostic Test: CMR based measurement of cardiotoxicity
- Other: biosampling for scientific research in study-specific biobank
Primary outcomes (1)
- measure
- Change of T2-weighted myocardial relaxation time in cardiac magnetic resonance imaging
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available