Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Aria Under Receiver Operating Characteristic (ROC) Curve
研究概览
简要总结
Phi-Bra is a prospective and monocentric pilot study to assess the diagnostic capability of an innovative bra prototype to detect breast cancer, compared to the current standard of care: the mammography.
The Phi-Bra prototype is designed with sensors measuring different parameters simultaneously such as impedance and temperature.
The bra will be tested on patients without breast lump (American College of Radiology (ACR) 1 et 2 Birads classification) and with breast lump (ACR 4b, c ou ACR 5 Birads classification).
The aim of this pilot study is to compare the results obtained by Phi-Bra to the ones obtained by mammography.
The Phi-Bra study is classified as clinical investigation category 4.4 based on the European Union (EU) regulation (DM 2017/745).
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and
- •No breast cancer surgery background
- •Bra size : S/M or M/L
- •Specific criteria for the "no breast lump" cohort:
- •Negative mammography result (ACR 1 a 2).
- •Specific criteria for the "breast lump" cohort:
- •Suspicious breast lump discovered during the mammography (ACR 4b ou c ou ACR 5) and for which there is an indication of microbiopsy.
排除标准
- •Breast cancer background (surgery or radiotherapy)
- •Breast lump classified as ACR 3 ou ACR 4a during the mammography
结局指标
主要结局
Aria Under Receiver Operating Characteristic (ROC) Curve
时间窗: The day of inclusion
The diagnostic performance of Phi-Bra to assess breast lump will be assessed by evaluating the ROC Area Under Curve (AUC), the reference being mammography as gold standard.
次要结局
- impedance optimal threshold(The day of inclusion)
- Correlation between lump volume and device impedance(The day of inclusion)