Ultrasound Tomography Using SoftVue in Diagnosing Women With Breast Cancer
Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner
研究概览
详细说明
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.
OUTLINE:
Patients undergo ultrasound tomography using SoftVue. Some patients also undergo MRI of the breast.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Michigan
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Detroit、Michigan、美国、48201
- Barbara Ann Karmanos Cancer Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Diagnostic (SoftVue ultrasound tomography)
Patients undergo ultrasound tomography using SoftVue.
Some patients also undergo MRI of the breast.
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Undergo ultrasound tomography using SoftVue
Undergo MRI of the breast
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluation the SoftVue system with respect to spatial resolution, contrast, sound speed resolution, and attenuation resolution
大体时间：At time of procedure
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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.
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At time of procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Ability of the system to identify pathological features previously identified by other imaging modalities
大体时间：At time of procedure
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The sensitivity of the SoftVue system to identify pathologic features will be estimated with 95% confidence intervals using previous imaging studies as the gold standard.
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At time of procedure
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Percent agreement between SoftVue (ultrasound tomography classification) and MRI (MR Breast Imaging-Reporting and Data System [BIRADS] classification)
大体时间：At time of procedure
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Will be calculated along with 95% confidence intervals.
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At time of procedure
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Sound speed as a percentage measure of dense breast tissue
大体时间：At time of procedure
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Compare measured sound speed values against known values for the range of tissue types imaged (e.g.
fatty breasts should have average sound speeds consistent with known speeds for fatty tissue).
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At time of procedure
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合作者和调查者
调查人员
- 首席研究员：Alit Amit-Yousif, M.D.、Barbara Ann Karmanos Cancer Institute
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
ultrasound tomography的临床试验
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Centre Hospitalier Universitaire de la Réunion招聘中
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Helse Nord-Trøndelag HFNorwegian University of Science and Technology; St. Olavs Hospital完全的