2025-521573-14-00
Not yet recruiting
Phase 4
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
Robert Bosch Gesellschaft fuer medizinische Forschung mbH1 site in 1 country93 target enrollmentStarted: August 8, 2025Last updated:
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Robert Bosch Gesellschaft fuer medizinische Forschung mbH
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Changes in the T2-weighted relaxation time in myocardial mapping
Overview
Brief Summary
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.
Study Design
- Allocation
- Not Applicable
- Primary Purpose
- Cmr-onco
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion 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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Changes in the T2-weighted relaxation time in myocardial mapping
Changes in the T2-weighted relaxation time in myocardial mapping
Secondary Outcomes
- Further abnormal CMR findings (morphology, function, perfusion, LGE and residual parametric mapping (T1-weighted relaxation time, extracellular volume)) during and after completion of anthracycline-based chemotherapy, analyzed by two different investigators
- Troponin T and NT-proBNP before, during and after completion of anthracycline-based chemotherapy in correlation with CMR results
- Echocardiographically determined Global Longitudinal Strain before, during and after completion of anthracycline-based chemotherapy in correlation to CMR results
- Validation and/or identification of new biomarkers (e.g. genetic markers) using the biomaterials
Investigators
Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology (IKP)
Scientific
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Study Sites (1)
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