Open-label,Single Site,Pilot Clinical Investigation to Assess Detectability and Sizing of Invasive Breast Cancers,Detectability of Benign Breast Lesions,Differentiation Between Malignant and Benign Breast Lesions Using Wavelia # 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Assess the Detectability Rate of Malignant and Benign Breast Lesions.
研究概览
简要总结
The trialed investigational medical imaging device is a low-power microwave breast imaging system for cancer screening purposes. It is an active device which uses non-ionizing radiation.
Microwave imaging is an emerging imaging modality for the early detection of breast cancer. The physical basis of microwave imaging is the dielectric contrast between healthy and cancerous breast tissues at the microwave frequency spectrum.
This study is a pilot Clinical Evaluation of a microwave imaging system (Wavelia #2) for Breast Cancer Detection. The clinical data that will be collected in the context of this study is intended for the assessment of the imaging diagnostic capability and the safety of the investigational device.
详细描述
This study aims to enrol approximately 103 subjects presenting to the symptomatic breast unit with a breast abnormality who consent to undergo an Microwave Breast Imaging (MWBI) scan using the Wavelia #2 imaging system. The study uses an adaptive design to verify and validate the technical evolutions that have been integrated in the Wavelia# 2 prototype on a small patient dataset (30 patients). Once the technical performance has been established recruitment will continue to assess the clinical performance of the MBI system compared to standard of care reference imaging. The primary objectives of the study are to assess the performance of Wavelia # 2 in the detection of malignant and benign breast lesions, the sizing of malignant lesions for which post-surgery histology data will be available and the differentiation between benign and malignant breast abnormalities by means of features extracted from the MBI images.
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
- •Informed Consent
- •Female subjects with an investigator assessed discrete breast abnormality of size > 1cm
- •Able and willing to comply with the requirements of this study protocol
- •Negative urine pregnancy test on the day of microwave imaging procedure (if of childbearing potential)
- •intact breast skin (i.e., without bleeding lesion, no evidence of inflammation and/or erythema of the breast)
- •Able to comfortably lie reasonably still in a prone position for approximately 15 minutes
- •Have had biopsy more than 2 weeks prior to the microwave breast investigation (if applicable)
排除标准
- •Have a cup size of A or whose breast is deemed too small to allow MBI assessment in the opinion of the investigator
- •Are pregnant or breast-feeding
- •Have had surgery on either breast within the past 12 months
- •Have any active or metallic implant other than a biopsy clip
- •Would be unsuitable for an MBI scan or unlikely to follow the protocol in the opinion of the Investigator
结局指标
主要结局
Assess the Detectability Rate of Malignant and Benign Breast Lesions.
时间窗: 21 days
Endpoint: Percentage of malignant and benign breast lesions correctly detected with Wavelia MWBI
次要结局
- Correct Sizing of Breast Lesions With Wavelia MWBI(21 days)