Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 1,537
- 主要终点
- Image Quality
研究概览
简要总结
Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine) from September 2011 to December 2013. The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to generate additional data on the diagnostic efficacy, reliability and safety of Dotarem in Magnetic Resonance (MR) mammography.
详细描述
Diagnostic efficacy was assessed on the basis of image quality (5-stage scale from "excellent" to "very poor"), diagnosis and cytology test result. Safety was assessed on the basis of the frequency and seriousness of adverse drug reactions observed following the injection of Dotarem.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are scheduled for high-resolution MR mammography using the MRI contrast agent Dotarem
排除标准
- 未提供
结局指标
主要结局
Image Quality
时间窗: During MRI procedure
Image quality was evaluated on a 5-point scale: "excellent"; "good"; "moderate"; "poor" and "very poor".
Ability to Make a Diagnosis
时间窗: During MRI procedure
Ability to make a diagnosis was evaluated by answering "yes" or "no" to the question "Did the examination permit a diagnosis ?"
Diagnostic Results (Percentage of Patients Per Diagnosis)
时间窗: During MRI procedure
Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient.
Cytology Test Results (Percentage of Patients Per Cytology Test Result)
时间窗: During MRI procedure
Diagnoses were made according to the cytology test results. Percentage of patients per cytology test result was calculated. Multiple diagnoses were possible for the same patient.
Frequency of Adverse Drug Reactions
时间窗: From the beginning of the MR mammography procedure to 30-60 min after
The frequency of adverse drug reactions (serious and non-serious) that occurred following injection of Dotarem was recorded. Adverse drug reactions are adverse events related to the product administered.
次要结局
未报告次要终点