Serial Cardiac Magnetic Resonance Imaging (CMR) With Contrast Agents and Biomarker Analysis for the Detection of Cardiotoxicity Under Anthracycline-containing Cancer Therapy

NCT07528586 | Recruiting

• 1 other identifier: S00854
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cardiotoxicity; Anthracycline-induced Cardiotoxicity

Keywords

anthracycline; cardiotoxicity; cardiac magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Change of T2-weighted myocardial relaxation time in cardiac magnetic resonance imaging

  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.

  Baseline (before anthracycline administration), after 4-9 weeks (depending on the anthracycline-based treatment regimen used), 3 months after completion of therapy, and 12 months after completion of therapy.

Secondary Outcomes (5)

• abnormal CMR findings regarding morphology and function

  Baseline (before anthracycline administration), after 4-9 weeks (depending on the anthracycline-based treatment regimen used), 3 months after completion of therapy, and 12 months after completion of therapy.

• abnormal CMR findings regarding late gadolinium enhancement (LGE)

  Baseline (before anthracycline administration), after 4-9 weeks (depending on the anthracycline-based treatment regimen used), 3 months after completion of therapy, and 12 months after completion of therapy.

• abnormal CMR findings regarding additional parametric mapping (T1-weighted relaxation times, extracellular volume)

  Baseline (before anthracycline administration), after 4-9 weeks (depending on the anthracycline-based treatment regimen used), 3 months after completion of therapy, and 12 months after completion of therapy.

• Troponin T and NT-proBNP levels before, during, and after completion of anthracycline-based chemotherapy, correlated with CMR findings

  Baseline (before anthracycline administration), after 4-9 weeks (depending on the anthracycline-based treatment regimen used), 3 months after completion of therapy, and 12 months after completion of therapy.

• Echocardiographically assessed global longitudinal strain before, during, and after completion of anthracycline-based chemotherapy, correlated with CMR findings.

  Baseline (before anthracycline administration), after 4-9 weeks (depending on the anthracycline-based treatment regimen used), 3 months after completion of therapy, and 12 months after completion of therapy.

Other Outcomes (1)

• Validation and/or identification of novel biomarkers on collected biomaterials (blood, stool, urin) using genetic testing, metabolomics, and cytokine analyses.

  Baseline (before anthracycline administration), after 4-9 weeks (depending on the anthracycline-based treatment regimen used), 3 months after completion of therapy, and 12 months after completion of therapy.

Study Arms (1)

Serial cardiac magnetic resonance imaging (CMR)

EXPERIMENTAL

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.

Diagnostic Test: CMR based measurement of cardiotoxicity; Other: biosampling for scientific research in study-specific biobank

Interventions

CMR based measurement of cardiotoxicity DIAGNOSTIC_TEST

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

Serial cardiac magnetic resonance imaging (CMR)

biosampling for scientific research in study-specific biobank OTHER

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.

Serial cardiac magnetic resonance imaging (CMR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients with a recommendation for antineoplastic therapy including at least four administrations of an anthracycline

You may not qualify if:

• 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

Sponsors & Collaborators

• Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF): lead

Study Sites (1)

Robert Bosch Gesellschaft für Medizinische Forschung mbH

Stuttgart, 70376, Germany

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Central Study Contacts

Matthias Prof. Dr. med. Schwab

CONTACT

0049 + 0711-8101 3700; matthias-schwab@ikp-stuttgart.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: No investigational medicinal products are being tested in this clinical trial; instead only diagnostic procedures are being investigated. Study population is defined as patients who are to be treated with at least 4 cycles of anthracycline-based chemotherapy. The anthracycline-based chemotherapy is standard of care therapy and is administered independently of the study. The standard anthracycline-based chemotherapy is not the subject of this study, but rather is its basis.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: April 14, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)