Serial contrast cardiac MRI and biomarker testing to detect anthracycline-related heart damage
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
NA · Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) · NCT07528586
This study tries to see if repeated contrast cardiac MRI plus blood, urine, and stool biomarker checks can find early heart damage in people getting anthracycline chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 93 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) (other) |
| Drugs / interventions | chemotherapy, radiation, cyclophosphamide |
| Locations | 1 site (Stuttgart) |
| Trial ID | NCT07528586 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults scheduled to receive anthracycline-based chemotherapy with at least four planned anthracycline administrations, who have not previously received anthracyclines and can undergo contrast-enhanced MRI, are ideal candidates.
Not a fit: Patients who previously received anthracyclines, are treated with liposomal anthracyclines or fewer than four anthracycline doses, have recent exposure to other cardiotoxic drugs, have pre-existing cardiac involvement (e.g., amyloidosis), or cannot undergo contrast MRI are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could detect heart injury earlier so doctors can adjust cancer treatment or start heart-protecting therapy sooner to reduce long-term cardiac damage.
How similar studies have performed: Prior studies indicate CMR and cardiac biomarkers can reveal chemotherapy-related cardiac changes, but serial contrast-enhanced relaxation time mapping during anthracycline therapy is an emerging approach still being refined.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Stuttgart
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiotoxicity, Anthracycline-induced Cardiotoxicity, anthracycline, cardiotoxicity, cardiac magnetic resonance imaging