NCT03470051已完成不适用
A Prospective Multi-center Case Collection Study of Breast Imaging Examinations From Women With Non-suspicious Breast Masses to Correlate the Calculated Mass Doubling Time Using Quantitative Transmission Ultrasound (QT Ultrasound) With Mass Histology.
QT Ultrasound LLC2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2018年2月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Breast mass doubling time change
研究概览
简要总结
This is a prospective case collection study to collect cases for subsequent statistical studies and future reader studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Age 18 or older
- •Willing to receive QT Ultrasound Breast Scans
- •Willing to undergo an ultrasound-guided needle breast biopsy if performed after enrollment in the study
- •Willing and able to provide Informed Consent prior to any research-related procedure(s)
- •Have an identified solid non-suspicious breast mass
排除标准
- •Currently breastfeeding
- •Magnetic material in the chest which in the judgement of the Principal Investigator would interfere or be impacted by the magnets utilized with the study device.
- •Not willing to provide information for primary care physician
- •History of breast cancer
- •History of treated or untreated cancer of a non-breast origin which in the judgment of the Principal Investigator would be a concern for metastatic disease to the breast
- •Physical inability to tolerate the QT scan, i.e. inability to lie prone and still for up to 30 minutes at a time
- •Open wounds, sores or skin rash present on the breast(s) or nipple discharge from the scanned breast(s)
- •Breasts too large for scanner, i.e. bra size larger than DDD or inability to successfully "fit" breast after the subject is placed on scanner
- •Body weight greater than 400 lbs. (180 kg)
- •Concurrent disease or condition which in the judgment of the Principal Investigator disqualifies the subject from participating in the study
结局指标
主要结局
Breast mass doubling time change
时间窗: 90 days
The change in calculated mass doubling time using Quantitative Transmission Ultrasound (QT Ultrasound) from a minimum of two study timepoints will be measured and compared to mass histology.
次要结局
未报告次要终点
研究者
研究点 (2)
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