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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
EU CTIS ID: 2025-521573-14-00
What this study is testing
The aim of the study is to analyze whether CMR is potentially suitable for the early detection of myocardial damage in oncology patients receiving anthracycline treatment.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Female and male persons > 18 years of age
- Patients to be treated with at least 4 cycles of anthracycline-based antineoplastic therapy
- Written informed consent form
You likely can't join if
- Lack of capacity to consent
- Patients who have already received anthracycline therapy
- Persons who have received therapy with the following myocardial-toxic drugs within the last 6 months prior to study inclusion - High-dose cyclophosphamide (>1000mg/m2, >10mg/kg) - HER2 inhibitors - VEGF inhibitors - BCR-ABL inhibitors - BRAF inhibitors - MEK inhibitors - Immune checkpoint inhibitors (CTLA-4 inhibitors, PD-1 inhibitors, PD-L1 inhibitors)
- Therapy with fewer than 4 planned cycles of antracycline-containing therapy (e.g. induction therapy for AML)
- Therapies in which antracyclines are not applied in every cycle
- Planned invasive cardiac procedure during the study period
See the full eligibility criteria
- Female and male persons > 18 years of age
- Patients to be treated with at least 4 cycles of anthracycline-based antineoplastic therapy
- Written informed consent form
- Lack of capacity to consent
- Patients who have already received anthracycline therapy
- Persons who have received therapy with the following myocardial-toxic drugs within the last 6 months prior to study inclusion - High-dose cyclophosphamide (>1000mg/m2, >10mg/kg) - HER2 inhibitors - VEGF inhibitors - BCR-ABL inhibitors - BRAF inhibitors - MEK inhibitors - Immune checkpoint inhibitors (CTLA-4 inhibitors, PD-1 inhibitors, PD-L1 inhibitors)
- Therapy with fewer than 4 planned cycles of antracycline-containing therapy (e.g. induction therapy for AML)
- Therapies in which antracyclines are not applied in every cycle
- Planned invasive cardiac procedure during the study period
- Known cardiac involvement of an existing disease, e.g. amyloidosis
- Treatment with liposomal forms of therapy, such as liposomal daunorubicin/cytarabine (CPX-351) or liposomal doxorubicin
- Radiotherapy with a thoracic radiation field that was performed prior to the planned anthracycline-containing therapy (radiotherapy for non-thoracic lesions prior to study inclusion is not considered an exclusion criterion)
- Simultaneous participation in another clinical trial or previous participation in another clinical trial in the last 3 months prior to study inclusion
- Kidney damage with a GFR <30 ml/min/1.73 m²
- Patients in the perioperative phase of a liver transplantion
- Metal implants, e.g. cardiac pacemakers, which are a contraindication for an MRI examination
- Vulnerable population (persons who are unable to protect and represent their own interests with regard to illness, disability, mental illness, intellectual development, cognitive impairment and prisoners) are not included in this study
- Pregnant or breastfeeding women
- Known hypersensitivity to contrast agents containing gadolinium
- Patient information not possible (e.g. language barrier)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.