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CardiotoxicityCMR-OnkoNCT07528586

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

A study testing CMR based measurement of cardiotoxicity and biosampling for scientific research in study-specific biobank in people with Cardiotoxicity and Anthracycline-induced Cardiotoxicity, run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CMR based measurement of cardiotoxicity and biosampling for scientific research in study-specific biobank
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteGermany
Study dates
4 Mar 2026to Mar 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 23Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Matthias Prof. Dr. med. Schwab contact

0049 + 0711-8101 3700

matthias-schwab@ikp-stuttgart.de

Germany1 site, 1 recruiting
  • Robert Bosch Gesellschaft für Medizinische Forschung mbH

    Stuttgart, 70376

    Matthias Prof. Dr. med. Schwab, 0049 + 0711-8101 3700, matthias-schwab@ikp-stuttgart.de

    Recruiting

Other trials in Germany

About this study

Official title: 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

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.

Read more

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
Read the detailed description

The goal of the trial is the early detection of cardiotoxicity in patients treated with anthracycline-based chemotherapy as standard of care therapy. For clarification: Standard anthracycline-based chemotherapy is administered independently of the study and is not the subject of this study, but rather is its basis. No investigational medicinal products are being tested in this clinical trial; instead only diagnostic procedures are being investigated.

Since current diagnostic methods-such as troponin T, NT-proBNP, electrocardiography, and echocardiography-are limited in their ability to detect early myocardial injury, the study aims to identify early myocardial damage using cardiac magnetic resonance imaging (CMR).

Enrolled participants will be stratified into risk groups using the HFA-ICOS score and-depending on the risk category-monitored according to current ESC guidelines using electrocardiography, echocardiography, and serial measurements of troponin T and NT-proBNP.

Preclinical data suggest that anthracyclines may impair myocardial function not only as a result of cumulative dosage over time but also during the early stages of therapy. The investigators therefore evaluate the use of CMR for the early detection of myocardial alterations during anthracycline therapy.

CMR examinations will be scheduled according to the administered cumulative dose of anthracyclines. Following a baseline evaluation prior to the initiation of therapy, the first follow-up CMR examination will be performed after approximately half of the preplanned cumulative anthracycline dose has been administered. A third CMR examination will be conducted after completion of therapy. Twelve months after therapy completion, an end-of-study CMR examination will be performed to assess persistent myocardial changes.

The primary endpoint is the measurement of myocardial relaxation times. Given the early time point of evaluation, additional CMR parameters will also be analyzed, including variations in cardiac morphology, cardiac function, late gadolinium enhancement, and myocardial perfusion.

Currently, both the proportion of participants potentially affected by early myocardial alterations during anthracycline therapy and the underlying pathophysiological mechanisms remain unclear. The study therefore seeks to identify biomarkers or genetic polymorphisms associated with an increased risk of early myocardial injury. For this purpose, blood, urine, and stool samples will be collected for inclusion in a biobank and analyzed for polymorphisms or mutations in genes such as CYBA, RAC2, NCF4, ABCC1, ABCC5, ABCB4, SLC22A17, SLC22A7, SLC28A3, SLC10A2, HAS3, CBR3, RARG, CELF4, and SLC22A3. In addition, anthracycline metabolites and cytokine profiles, such as IL-6 and TNF-α, may be measured.

Being tested
CMR based measurement of cardiotoxicity, biosampling for scientific research in study-specific biobank
Keywords
anthracycline, cardiotoxicity, cardiac magnetic resonance imaging
Medical subject headings
Cardiotoxicity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CMR based measurement of cardiotoxicityDiagnostic 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

  • biosampling for scientific research in study-specific biobankOther

    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.

Study groups in NCT07528586
Study groupRoleWhat they receive
Serial cardiac magnetic resonance imaging (CMR)ExperimentalIn 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.
Receives: Diagnostic Test: CMR based measurement of cardiotoxicity; Other: biosampling for scientific research in study-specific biobank

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. abnormal CMR findings regarding morphology and function

    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.

    Measured: 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.

  2. abnormal CMR findings regarding late gadolinium enhancement (LGE)

    CMR is performed on a 1.5T Siemens Magnetom Aera. 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.

    Measured: 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.

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

    CMR is performed on a 1.5T Siemens Magnetom Aera. T1 mapping is performed using a MOLLI sequence before and 20 minutes after contrast agent administration.

    Measured: 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.

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

    Measured: 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.

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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study start4 Mar 2026
  3. Primary completionAug 2029 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
93 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07528586
Sponsor's protocol ID
S00854
Acronym
CMR-Onko
Status last verified
Apr 2026
First submitted
5 Feb 2026
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CMR based measurement of cardiotoxicity and biosampling for scientific research in study-specific biobank in people with Cardiotoxicity and Anthracycline-induced Cardiotoxicity, run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Matthias Prof. Dr. med. Schwab (0049 + 0711-8101 3700, matthias-schwab@ikp-stuttgart.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of T2-weighted myocardial relaxation time in cardiac magnetic resonance imaging (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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