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Early detection of heart damage using cardiac magnetic resonance imaging in cancer patients receiving doxorubicin, epirubicin, pixantrone and other anthracyclines

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What is this study about?

This clinical trial focuses on patients receiving anthracycline-based cancer therapy. Anthracyclines are powerful cancer medications that include doxorubicin, epirubicin, pixantrone, idarubicin, daunorubicin, and mitoxantrone. These medications are given through an intravenous line as part of standard cancer treatment.

The study aims to determine if cardiac magnetic resonance imaging (CMR) can detect early heart damage in patients receiving anthracycline treatment. During CMR scans, a special substance called contrast agent is used to make certain parts of the heart more visible in the images.

Throughout the treatment period, which may last up to 8 months, participants will undergo several CMR scans and blood tests. The study will look for changes in heart tissue and measure certain substances in the blood that might indicate heart damage. Participants will also receive regular heart ultrasound tests called echocardiograms to monitor their heart function during treatment.

1 Initial cardiac assessment

You will undergo a baseline cardiac magnetic resonance imaging (CMR) scan with contrast agents before starting the chemotherapy treatment

Blood samples will be collected to measure cardiac markers (Troponin T and NT-proBNP)

An echocardiogram will be performed to assess heart function

2 Chemotherapy treatment initiation

You will receive at least 4 cycles of anthracycline-based chemotherapy through an intravenous line

The medications may include one of the following: doxorubicin, epirubicin, idarubicin, mitoxantrone, or daunorubicin

Treatment will be administered according to your standard cancer care plan

3 Monitoring during treatment

Regular cardiac magnetic resonance imaging scans will be performed to monitor your heart

Blood samples will be collected to check cardiac markers

Echocardiogram tests will be conducted to assess heart function

Additional blood samples may be collected for research purposes

4 Final assessment

After completing chemotherapy, you will have a final cardiac magnetic resonance imaging scan

Final blood tests will be performed to measure cardiac markers

A final echocardiogram will assess your heart function

The study will track your heart health through these tests until completion

Who Can Join the Study?

  • You must be over 18 years old
  • You can be either male or female
  • You must be scheduled to receive at least 4 cycles of anthracycline-based cancer treatment (a specific type of chemotherapy medication used to treat cancer)
  • You must be able to understand and sign a written informed consent form that explains all study procedures and risks

Who Cannot Join the Study?

  • Known allergy or contraindication to gadolinium contrast agents (substances used during magnetic resonance imaging)
  • Claustrophobia (fear of confined spaces) that would prevent magnetic resonance imaging
  • Presence of any metallic implants or devices not compatible with magnetic resonance imaging (such as pacemakers, metal clips, or certain artificial joints)
  • Renal insufficiency (poor kidney function) with estimated glomerular filtration rate below 30 ml/min
  • Previous history of cardiotoxicity (heart damage) from any cause
  • Inability to lie flat for approximately 45 minutes during the scanning procedure
  • Pregnancy or breastfeeding
  • Any serious medical condition that, in the opinion of the study team, would make participation unsafe
  • Previous treatment with anthracycline-based therapy (a type of cancer medication)
  • Participation in another clinical trial within the past 30 days

Where you can join this trial?

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Other Sites

Site Name City Country Status
Robert Bosch Gesellschaft fuer medizinische Forschung mbH Stuttgart Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
20.06.2025

Trial locations

Investigated drugs:

Anthracycline is a type of chemotherapy medication used to treat various types of cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and multiplying. While effective against cancer, this medication requires careful monitoring as it may affect heart function.

Contrast agents are special substances used during cardiac magnetic resonance imaging (CMR) to help create clearer and more detailed images of the heart. These agents are typically injected into a vein during the imaging procedure and help doctors better visualize blood flow and heart tissue structure.

These medications are used together in this study to monitor how anthracycline chemotherapy might affect the heart, using contrast-enhanced magnetic resonance imaging to detect any early signs of heart damage.

Investigated diseases:

Anthracycline-induced Cardiotoxicity – A condition that occurs when anthracycline chemotherapy medications affect heart function. The damage typically develops gradually as the medication affects the heart muscle cells. Changes can occur in the heart’s ability to pump blood effectively, and the heart muscle may become weaker over time. The condition can develop during treatment or months after receiving anthracycline therapy. Early changes often occur at the cellular level in the heart muscle tissue before visible symptoms appear.

Myocardial Damage – A condition where heart muscle tissue becomes injured or damaged. The damage can affect the heart’s normal pumping function and its ability to contract properly. The heart muscle cells can become weakened or damaged through various mechanisms. Changes in the heart tissue can be detected through specialized imaging techniques. The condition may develop gradually and affect different areas of the heart muscle.

Trial ID:
2025-521573-14-00
Protocol code:
S00854
Trial Phase:
Therapeutic confirmatory (Phase III)

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