NCT01522300终止2 期
Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité
Centre Jean Perrin2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- To calculate the sensitivity and specificity of both types of imaging (mammography and Tomosynthesis) with respect to number of tumors multicentric and multifocal identified through MRI.
研究概览
简要总结
The main objective of the study is to assess the sensitivity and specificity of Tomosynthesis in detecting the multicentricity of mammary tumor.
详细描述
The secondaries objectives of the study are:
- Sensitivity and specificity in detecting multifocality of breast tumor
- Sensitivity and specificity of Tomosynthesis in the detection of contralateral tumors
- Predetermination of potential targets for ultrasound
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age> 18 years.
- •Patients with a breast tumor, regardless of the stage and size
- •Compulsory affiliation to a social security system.
- •Obtaining informed consent in writing, signed and dated.
排除标准
- •Patients with cognitive or psychiatric disorders.
- •Patient deprived of liberty by a court or administrative.
- •Patients with indications against the achievement of MRI, mammography and tomosynthesis
- •Pregnant Women
结局指标
主要结局
To calculate the sensitivity and specificity of both types of imaging (mammography and Tomosynthesis) with respect to number of tumors multicentric and multifocal identified through MRI.
时间窗: January 2013
To calculate the sensitivity and specificity of both types of imaging (mammography and Tomosynthesis) with respect to number of tumors multicentric and multifocal identified through MRI. The other parameters VPN, VPP will also be calculated and discussed.
次要结局
未报告次要终点
研究者
研究点 (2)
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