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临床试验/NCT07471672
NCT07471672Enrolling By Invitation不适用

Efficacy of Spot Compression Ultrasound Compared to Traditional Breast Ultrasound

Duke University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
25
试验地点
1
主要终点
Number of breast masses detected

研究概览

简要总结

The purpose of this study is to determine the efficacy of targeted breast ultrasound ("ultrasound in the grid") performed concurrently with diagnostic mammogram during breast compression with an open mammogram paddle in lesion detection when compared to standard diagnostic breast ultrasound. Open paddle spot tomosynthesis and ultrasound in the grid images will be compared to the standard of care, and outcome measures will include comparing accuracy of lesion detection with the new technique versus the standard of care and differences in time to acquire the images for the new technique versus the current standard of care. Radiologists will also review the different sets of images and give confidence scores of lesion correspondence between mammogram and ultrasound. This will be a pilot study of 25 patients to demonstrate proof of concept and is intended to lay the foundation for future funded research with a larger patient population.

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
30 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Mass visible on both diagnostic mammogram and ultrasound
  • Mass within the size limit to be completely confined within an open grid mammogram paddle (less than 3 cm)

排除标准

  • 未提供

研究组 & 干预措施

Spot Compression Ultrasound

Experimental

This arm includes all participants enrolled in the study who will receive the experimental imaging technique

干预措施: Targeted ultrasound in the grid (Diagnostic Test)

结局指标

主要结局

Number of breast masses detected

时间窗: Single visit, up to approximately one hour

The primary outcome will be whether breast masses can be detected using an open mammogram spot tomosynthesis compression paddle and targeted ultrasound in the grid using the experimental technique.

次要结局

  • Time to acquire images(Single visit, up to approximately one hour)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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