A Prospective, Single-Center, Feasibility Study Assessing the Safety and Performance of the Multi-Modal UltraSound Tomography (MUST) Device in Identifying Malignant Breast Lesions as an Adjunct to Mammography
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,333
- 试验地点
- 2
- 主要终点
- Number of subjects with false positive (benign) breast lesions confirmed by biopsy
研究概览
简要总结
This is a single-center, pilot study being conducted to evaluate the safety and performance of the investigational device (MUST) in detecting malignant lesions in breast tissue.
详细描述
This is a single-center, prospective, pilot study in which all enrolled subjects will receive the same screening mammography procedures (i.e., 3D mammography plus MUST).
Subjects will have between 1 and 4 clinic visits. The number of visits will be based upon the mammography and MUST findings, and whether additional procedures, such as MRI, biopsy, or a repeat MUST are warranted.
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
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subject scheduled for routine screening mammogram
- •Not currently pregnant or breastfeeding
- •Age 40 to 74 years, inclusive
- •Weight less than 115 kg
- •Able to provide written informed consent
- •Willing to comply with study protocol and follow-up recommendations.
排除标准
- •Breast implants
- •Signs or symptoms of breast disease including changes in the size or shape of breast tissue, palpable lump, bloody or spontaneous clear nipple discharge, and/or eczema of the nipple
- •Weeping rash, open wounds, or unhealed sores on the breast
- •Bilateral mastectomy or unilateral mastectomy
- •Unable to lay prone on the scan table for up to 16 minutes
- •Unable to have breast positioned into the MUST device
- •Any breast surgeries in the past 12 months
- •History of cancer diagnosis and/or treatment in the past 5 years.
- •Unable or unwilling to undergo MRI if indicated
结局指标
主要结局
Number of subjects with false positive (benign) breast lesions confirmed by biopsy
时间窗: 14 days
Specificity of MUST plus mammography versus mammography alone
Number of subjects with true positive (malignant) breast lesions confirmed by biopsy
时间窗: 14 days
Sensitivity of MUST plus mammography versus mammography alone
次要结局
- For subjects test positive on mammography (initial BI-RADS score of 0 followed by an additional imaging BI-RADS score of 4 or 5) who undergo biopsy, comparison of MUST and MRI results with biopsy results(60 days)
- Listing of adverse events experienced by subjects(6 months)
- Number of subjects with true positive and false positive breast lesions at the 6 month follow up (if applicable) and the 12 month follow up phone call.(12 months)
- Number of true positive and false positive breast lesions categorized by BI-RADS breast density category as determined by the screening mammogram(14 days)
- For subjects who undergo biopsy, comparison of MUST results with biopsy results(60 days)