Serial contrast cardiac MRI and biomarker testing to detect anthracycline-related heart damage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants receive a baseline contrast-enhanced CMR with relaxation time mapping and repeat CMRs scheduled according to cumulative anthracycline dose to measure changes before, during, and after therapy. The trial pairs serial CMR with routine cardiac monitoring (ECG, echocardiography including global longitudinal strain) and serial troponin T and NT-proBNP measurements, and stratifies patients by HFA-ICOS risk with monitoring guided by ESC recommendations. Blood, urine, and stool samples are banked for biomarker discovery and correlation with imaging findings. No experimental drugs are given; anthracycline chemotherapy is provided as part of standard cancer care.

Why it matters

Who can join: the full rules

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)

Where it's running

• Robert Bosch Gesellschaft für Medizinische Forschung mbH
  Stuttgart, Germany Recruiting

Study contacts

• Study coordinator: Matthias Prof. Dr. med. Schwab
• Email: matthias-schwab@ikp-stuttgart.de
• Phone: 0049 + 0711-8101 3700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.