Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 657
- 试验地点
- 2
- 主要终点
- Evaluation the SoftVue system with respect to spatial resolution, contrast, sound speed resolution, and attenuation resolution
研究概览
简要总结
This clinical trial studies ultrasound tomography using SoftVue in diagnosing women with breast cancer. New diagnostic procedures, such as ultrasound tomography using SoftVue, may help find and diagnose breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. Determine the in-vivo imaging potential of SoftVue through 3-dimensional (3-D) breast imaging.
II. Acquire data for SoftVue evaluation from a cohort of 100 women receiving standard ultrasound (US) evaluation as follow-up to mammographic or palpable abnormalities and construct reflection, sound speed and attenuation images with SoftVue.
III. Evaluate the ability of SoftVue to detect dominant breast findings (i.e. major normal landmark architecture) or masses previously identified with standard diagnostic evaluation (palpation, mammography, standard US) using standard clock position and radial distance measurements from the nipple.
IV. Conduct tomographic (i.e. slice-by-slice) comparison of SoftVue with magnetic resonance imaging (MRI) findings from a subgroup of 50 patients.
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 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled for mammogram, breast ultrasound and/or breast MRI
- •Breast size less than 22 cm diameter (ring diameter is 22cm)
- •Able to read or understand and provide informed consent
- •Weight < 350lbs (patient bed max weight)
- •Non-pregnant and non-lactating
- •No open breast or chest wounds
- •No active skin infection
- •No serious medical or psychiatric illnesses that would prevent informed consent
排除标准
- 未提供
结局指标
主要结局
Evaluation the SoftVue system with respect to spatial resolution, contrast, sound speed resolution, and attenuation resolution
时间窗: At time of procedure
For each type of resolution, observed values will be averaged over slices for each participant and compared to milestone values. The proportion of individuals whose images meet the milestone criteria will be reported with 95% confidence intervals calculated using Wilson's method.
次要结局
- Percent agreement between SoftVue (ultrasound tomography classification) and MRI (MR Breast Imaging-Reporting and Data System [BIRADS] classification)(At time of procedure)
- Ability of the system to identify pathological features previously identified by other imaging modalities(At time of procedure)
- Sound speed as a percentage measure of dense breast tissue(At time of procedure)
研究者
Alit Amit-Yousif
Principal Investigator
Barbara Ann Karmanos Cancer Institute