2025-521573-14-00招募中4 期
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 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2025年8月8日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Changes in the T2-weighted relaxation time in myocardial mapping
研究概览
简要总结
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.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Cmr-onco
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Changes in the T2-weighted relaxation time in myocardial mapping
Changes in the T2-weighted relaxation time in myocardial mapping
次要结局
- 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
研究者
Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology (IKP)
Scientific
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
研究点 (1)
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