Early Detection of Patients at Risk of Developing Anthracycline Cardiotoxicity With TEP/CT -FDG
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Evaluation of the cardiac uptake of 18F-FDG
研究概览
简要总结
Management of patients with lymphoma is based on the administration of a chemotherapy containing anthracyclines (ATC), and allows cure rates of 65% to 80% at 5 years. The administration of ATCs can lead to an increase in the risk of the Left Ventricular Systolic dysfunction (LVSD) which ranges from 6 to 15% at 1 year, and of heart failure from which impact at 3.5 years can reach 5%. The major issue in the management of this toxicity is the early identification of this population for monitoring and prevention. No pharmacological intervention strategy is currently recommended.
According to the recommendations of the European Society of Cardiology, this identification is based on the measurement of the left ventricular ejection fraction (LVEF) and the overall longitudinal strain (SLG) before and after the last administration of ATC ( at D84 or D126, depending on the duration of the chemotherapy protocol). Recent studies have evaluated the diagnostic performance of earlier strategies highlighting the benefit of SLG measured after 150 mg / m2 of ATC (D42). However, the tools are lacking to detect these patients as close as possible to the onset of ATC, a necessary condition for effective secondary prevention. The hypothesis is that an early assessment of myocardial binding of 18F-FDG, analyzed during the first routine PET / CT scan as part of the assessment of the response to chemotherapy (D42) should verify a population at risk of developing LVSD at 1 year.
详细描述
This is a study that evaluates the sensitivity of the cardiac uptake of 18F-FDG measured on D42 of the administration of ATCs to identify at 1 year the patients at risk of occurrence of a LVSD defined by a drop of more than 10 units of the LVEF and LVEF <53%.
Design : A multicentre clinical trial with 11 sites participating in the study.
Sample size : 484 patients
Duration of inclusion: 25 months Patient observation period: 12 months Total duration: 37 months
Assessment :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of at least 18 years of age, treated as part of an initial extension assessment (staging) of a lymphoma (Hodgkin's or non-Hodgkin's)
- •Treatment with a chemotherapy protocol containing Anthracyclines (ABVD protocol, enhanced BEACOPP, R CHOP, CHOP, CHOEP, EPOCH, ACVBP)
- •Signed informed consent
- •Affiliation to a social security system (AME excepted)
排除标准
- •FEVG<53%
- •Cardiological symptomatic patient (Dyspnea, angina, palpitations, syncope, left ventricular insufficiency, right ventricular insufficiency, overall heart failure)
- •Patient for whom PET/CT invalidates the presence of lymphoma (Hodgkin's or non-Hodgkin's)Uncontrolled blood pressure (AP) (systolic AP > 140 mm Hg and/or diastolic AP > 90 mmHg)
- •Myocardial infarction in the 3 months prior to inclusion
- •Heart failure in the 3 months prior to inclusion
- •Severe symptomatic or asymptomatic mitral valvulopathy
- •Symptomatic or asymptomatic tight aortic stenosis
- •Atrial Fibrillation
- •Pregnant or lactating woman
- •Hypersensitivity to 18F-FDG
- •Patient under guardianship or curatorship
- •Patient under State Medical Aid
结局指标
主要结局
Evaluation of the cardiac uptake of 18F-FDG
时间窗: Day 28 +/- 7 days, Day 42 +/- 7 days or Day 56 + 4 days
Evaluation of the cardiac uptake of 18F-FDG measured on Day 42 of the administration of ATCs to identify at 1 year the patients at risk of occurrence of a LVSD defined by a drop of more than 10 units of the LVEF and LVEF \<53%.
次要结局
- The specificity, the negative predictive value and the positive predictive value of 18F-FDG cardiac uptake(Day 28 +/- 7 days, Day 42 +/- 7 days or Day 56 + 4 days)
- Evaluate with the echocardiography performed at the end of chemotherapy the sensitivity, specificity, the negative predictive value and the positive predictive value of the SLG change (difference of(Day 84 and Day 126)
- Compare PET/CT sensitivities at D28 +/- 7 days, D42 +/- 7 days or D56 + 4 days and SLG variation between the start and the end of chemotherapy administration (D84 or D126 depending on the chemotherapy protocol) to identify patients at risk of LVSD at 1 y(Day 28 +/- 7 days, Day 42 +/- 7 days or Day 56 + 4 days)
- Search for an intensity threshold in Standard Uptake Value (SUV)) of global 18F-FDG uptake to predict the occurrence of LVSD at 1 year.(1 year)
- Evaluate the concordance between the result of the 18F-FDG cardiac uptake performed at D28 +/- 7 days, D42 +/- 7 days or D56 + 4 days assessed by the investigator and the result obtained at the centralized review.(Day 28 +/- 7 days, Day 42 +/- 7 days or Day 56 + 4 days)