A Multicentric, Single Arm, Prospective, Stratified Clinical Investigation to Evaluate the Ability of MammoWave in Breast Lesions Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 353
- 试验地点
- 6
- 主要终点
- MammoWave sensitivity (number of 'true positive' results)
研究概览
简要总结
This is a multicentric, single arm, prospective, stratified by breast density clinical investigation using Mammowave that is a device, which uses microwaves instead of ionizing radiation (X-ray)for breast lesions(BL) detection. Specifically, Mammowave employs a novel technique which generates images by processing very low power (<1 mW) microwaves. The exam takes few minutes per breast and is performed with the patient lying in a comfortable facing down position. Mammowave is safe to be used at any age, in any condition (pregnancy, specific illness) and for unlimited number of times.
详细描述
The number of participants will be 500 (for all the sites). The Study will be composed of two phases: a preliminary phase to 'optimize the imaging algorithm for each apparatus installed at each centre', where 15 healthy volunteers in each centre will be examined by MammoWave. In the second phase, the remaining people will be enrolled (Breast Lesions pts will be about 70% of total) and examined by MammoWave by the clinical investigator, and results will be compared with the effective diagnosis already obtained by standard clinical methods. BL includes malignant lesions (BC) and benign lesions, and may be palpable or non-palpable lesions. BL includes also isolated clustered microcalcifications.
At the end of the study, in each centre the clinical investigators will compare MammoWave output against the radiologist study output obtained using conventional exams.
In addition, at the end of the study, the MammoWave output will be centrally reviewed in blind by an independent radiologist in order to confirm the data and confirm centrally the comparisons performed locally. The primary goal of the clinical study is to assess Mammowave's ability in BL detection and differentiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 是
入选标准
- •Signed Informed consent Form
- •Adult ≥18 years old
- •Having a radiologist study output obtained using conventional exams (such as breast specialist visit and mammography and/or ultrasound and/or magnetic resonance imaging) within the last month.
- •Patients willing to comply with study protocol and recommendations.
- •Patients with intact breast skin (i.e. without bleeding lesion, scar).
排除标准
- •Patients that are enrolled in another clinical study
- •Patients who belong to any vulnerable group.
- •Patients with implanted electronics.
- •Patients who have undergone biopsy less than one week before MammoWave scan
- •Patients with breast implants
- •Patients with nipple piercings (unless they are removed before MammoWave exam).
- •Participation in other studies in the last month before screening
- •Pregnancy or breastfeeding
结局指标
主要结局
MammoWave sensitivity (number of 'true positive' results)
时间窗: During the procedure
MammoWave sensitivity (number of 'true positive' results) compared to Reference Standard
次要结局
- MammoWave specificity and sensitivity (against Reference Standard)(During the baseline)
- Absolute and rate agreement between different evaluator (i.e. local radiologist versus central)(Through study completion, an average of 1 year)
- Sensitivity for each breast density group(During the baseline)
- Patient satisfaction questionnaire.(During the baseline)
- Sensitivity for patients which had recent mammography(During the baseline)
- Percentage of correct BL localization in terms of quadrant (against Reference Standard)(During the baseline)