Early Detection of Cardiac Toxicity of Trastuzumab (Herceptin ®) in Patients Treated for Breast Carcinoma: Value of Magnetic Resonance Imaging
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 6
- 主要终点
- Proportions of late enhancement in patients with LV dysfunction as Herceptin ® and in a control group consisting of patients who did not have LV dysfunction after 6 months under the same treatment.
研究概览
简要总结
The main objective of this study is to compare the proportions of late enhancement in patients with Left ventricular (LV) dysfunction as Herceptin ® and in a control group consisting of patients who did not have LV dysfunction after 6 months under the same treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over 18 years
- •Free and informed consent signed
- •Histologically confirmed adenocarcinoma of the breast, metastatic or non-metastatic
- •LVEF> 50% angioscintigraphy before the start of treatment with Herceptin ®,
- •Overexpression of HER2 in the invasive component of the primary tumor (3 + 2 + according to ICH or with confirmation of positivity by FISH or CISH)
- •Patient receiving treatment with Herceptin ®,
- •Inclusion in the control group: patients treated with Herceptin ® episode without LV dysfunction,
- •For the inclusion in the Group LV dysfunction: the appearance of a decrease in LVEF during treatment with Herceptin ®, angioscintigraphy identified.
排除标准
- •Heart disease or serious medical conditions do not allow to administer Herceptin ® (documented history of heart failure, angina requiring treatment, severe dyspnoea at rest or oxygen dependency),
- •History of ischemic heart disease or myocarditis
- •Known allergy to trastuzumab, murine proteins or any of the excipients
- •Patients with an indication against the MRI (claustrophobia, ferromagnetic foreign body, pacemaker or implantable defibrillator, known allergy to gadolinium salts)
- •Renal impairment (creatinine clearance <60 ml / min according to the MDRD formula)
- •Arrhythmia atrial fibrillation,
- •Contraindications to the administration of Dotarem ®,
- •Patient unable to give informed consent,
- •Adult Trust,
- •Pregnant or lactating
- •Patient unable to undergo a medical for geographical, social or psychological.
研究组 & 干预措施
LV dysfunction group
Cardiac MRI
干预措施: Cardiac MRI (Other)
Control group
Cardiac MRI
干预措施: Cardiac MRI (Other)
结局指标
主要结局
Proportions of late enhancement in patients with LV dysfunction as Herceptin ® and in a control group consisting of patients who did not have LV dysfunction after 6 months under the same treatment.
时间窗: 2 years
A cardiac MRI is considered positive if demonstrated a late hyperintense from 15 to 20 minutes after injection of gadolinium chelate, whatever its size, topography subepicardial (intramyocardial) and without vascular systematization. The primary endpoint is the proportion of delayed enhancement in the LV dysfunction group and the control group.
次要结局
- Proportion of patients recovering at 6 months in the absence of late enhancement signal in MRI heart after injection of gadolinium and compare the results of biological assays(2 years)