Breast Microcalcifications Identified With MicroPure as a Marker for Malignancy Compared to Grayscale Ultrasound and Mammography (Using Biopsy as the Reference Standard)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 主要终点
- Number of microcalcifications seen on grayscale ultrasound
研究概览
简要总结
This clinical trial studies a new type of ultrasound technique, MicroPure, in detecting breast microcalcifications in patients undergoing biopsy for a breast abnormality. Ultrasound sends sound waves into the body, and the sound waves reflected back are interpreted by the machine into a grayscale image. MicroPure uses a filter that adjusts the brightness and gives color to the ultrasound images, which may allow doctors to better identify microcalcifications. Microcalcifications are tiny deposits of calcium in the breast that cannot be felt but can be detected by imaging. A group of microcalcifications may indicate that cancer is present.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate MicroPure relative to grayscale ultrasound imaging for the identification of microcalcifications with mammography as the reference standard.
SECONDARY OBJECTIVES:
I. Evaluate MicroPure compared to grayscale ultrasound imaging and mammography for the characterization of breast abnormalities associated with microcalcifications using biopsy results as the reference standard (sensitivity and specificity will be calculated).
II. Evaluate MicroPure relative to specimen x-ray imaging for the identification of breast microcalcifications with pathology as the reference standard.
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
- 否
入选标准
- •Give written informed consent
- •Be scheduled for a sonographic or stereotactic guided core needle biopsy or surgical excision for the evaluation of a breast lesion or abnormality containing microcalcifications seen on mammography
排除标准
- •Is clinically unstable, severely ill, or moribund
研究组 & 干预措施
Diagnostic (standard ultrasound, MicroPure, biopsy)
Patients undergo grayscale and MicroPure ultrasound imaging followed by sonographic or stereotactic guided core needle biopsy or surgical resection. Surgical specimens are then x-rayed.
干预措施: Ultrasound (Device)
Diagnostic (standard ultrasound, MicroPure, biopsy)
Patients undergo grayscale and MicroPure ultrasound imaging followed by sonographic or stereotactic guided core needle biopsy or surgical resection. Surgical specimens are then x-rayed.
干预措施: MicoPure ultrasound (Device)
Diagnostic (standard ultrasound, MicroPure, biopsy)
Patients undergo grayscale and MicroPure ultrasound imaging followed by sonographic or stereotactic guided core needle biopsy or surgical resection. Surgical specimens are then x-rayed.
干预措施: Biopsy of Breast (Procedure)
结局指标
主要结局
Number of microcalcifications seen on grayscale ultrasound
时间窗: Baseline
The number of microcalcifications seen on grayscale ultrasound will be recorded and compared to x-ray imaging of the area undergoing the biopsy procedure (as the reference standard). The difference in agreement between the two ultrasound modes (relative to mammography) will be assessed using McNemar's test for correlated proportions, where p-values less than 0.05 are considered significant. A dichotomous parameters indicating agreement with mammography with respect to the exact number of microcalcifications (as yes or no) will be calculated and compared.
Number of microcalcifications seen on MicroPure ultrasound
时间窗: Baseline
The number of microcalcifications seen on MicroPure ultrasound will be recorded and compared to x-ray imaging of the area undergoing the biopsy procedure (as the reference standard). The difference in agreement between the two ultrasound modes (relative to mammography) will be assessed using McNemar's test for correlated proportions, where p-values less than 0.05 are considered significant. A dichotomous parameters indicating agreement with mammography with respect to the exact number of microcalcifications (as yes or no) will be calculated and compared.
次要结局
- Number of microcalcifications determined by pathology findings(Baseline)