Serial Cardiac Magnetic Resonance Imaging (CMR) With Contrast Agents and Biomarker Analysis for t… (NCT07528586) | Clinical Trial Compass
RecruitingNot Applicable
Serial Cardiac Magnetic Resonance Imaging (CMR) With Contrast Agents and Biomarker Analysis for the Detection of Cardiotoxicity Under Anthracycline-containing Cancer Therapy
Germany93 participantsStarted 2026-03-04
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of T2-weighted myocardial relaxation time in cardiac magnetic resonance imaging
Timeframe: 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.
Trial details
NCT IDNCT07528586
SponsorRobert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)