Advanced Ultrasound Beamforming Methods for Breast Imaging
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Image quality
研究概览
简要总结
This study aims to investigate recent developments in ultrasound signal processing to determine if these new techniques can enhance the visibility of important features of interest in breast ultrasound images. Ultrasound signals obtained from both standard ultrasound imaging and ultrasound imaging combined with light (also known as photoacoustic imaging) will be investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Female adults (age >18 years) with at least one of the following:
- •Macrocalcification(s) detected in x-ray 2D or 3D mammography images
- •Macrocalcification(s) located next to cyst (or other identifiable landmark on an ultrasound image)
- •A cyst, mass, or finding detected in diagnostic/screening ultrasound or mammography
排除标准
- •(when performing ultrasound imaging only)
- •Children (age < 18 years) are excluded
- •(when performing ultrasound imaging with light, i.e., optoacoustic imaging)
- •Children (age < 18 years) are excluded
- •Is pregnant
- •Has open sores including insect bites, rash, poison ivy, and chafing on the skin of the ipsilateral breast
- •Is experiencing phototoxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfonamides, ampicillin, tetracycline
- •Is currently undergoing phototherapy
- •Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or is undergoing treatment for a photosensitive disease and is experiencing photosensitivity
结局指标
主要结局
Image quality
时间窗: baseline
compare advanced beamforming and benchmark against a conventional beamforming technique by measuring and comparing standard image quality metrics
Number of microcalcifications
时间窗: baseline
Subjective ratings
时间窗: baseline
Clinicians (members of study team) will be shown images and asked to provide subjective ratings of the images
Binary visibility of microcalcifications
时间窗: baseline
Clinicians (members of study team) will be shown images and record 'yes' if microcalcifications are present and 'no' if not.
Distinction of mass contents: solid vs. fluid
时间窗: baseline
After examining the coherence measurements obtained from advanced beamforming techniques, the investigators will determine the ability of this quantitative information to distinguish between solid and fluid-filled masses
Distinction of mass contents: benign vs. malignant
时间窗: baseline
After examining the coherence measurements obtained from advanced beamforming techniques, the investigators will determine the ability of this quantitative information to distinguish between solid malignant masses vs. solid benign masses
次要结局
- Number of false positives(baseline)
- Number of true positives(baseline)
- Number of true negatives(baseline)
- Number of false negatives(baseline)