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临床试验/NCT03544268
NCT03544268已完成4 期

Academic-Industrial Partnership for Translation of Acoustic Angiography

UNC Lineberger Comprehensive Cancer Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年3月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Sensitivity and Specificity

研究概览

简要总结

Purpose: The primary objective of this single arm study is to compare the sensitivity and specificity of acoustic angiography with traditional b-mode ultrasound in the distinction of malignant versus benign breast lesions. Secondary objectives include a comparison of area under the curve (AUC) for acoustic angiography versus b-mode ultrasound, and comparison of radiologist preference for the two imaging techniques for each of 3 lesion characteristics.

Participants: Sixty patients who are to have a clinical surgical breast biopsy based on results from pre-study standard of care (SOC) imaging will be recruited from the UNC Breast Clinic for participation in the study.

Procedures (methods): This is a one arm single center study of patients with suspicious breast lesions (BIRADS 4 or 5) from the UNC Breast Clinic that consent to undergo an acoustic angiography in conjunction with b-mode ultrasound prior to their scheduled biopsy.

详细描述

Increasing the sensitivity and specificity of diagnostic imaging in patients at high risk for breast cancer could provide substantial clinical benefit by improving diagnosis, preventing over-treatment, and reducing healthcare costs. Acoustic angiography is a new type of contrast enhanced ultrasound imaging which is specifically sensitive to microvascular structure and density. It evaluates tumor micro-vasculature and may provide a powerful prognostic tool for the diagnosis of breast cancer, and eventually for treatment evaluation.

Sixty patients who are to have a clinical surgical breast biopsy based on results from pre-study standard of care (SOC) imaging will be recruited from the UNC Breast Clinic for participation in the study. The primary objective of this single arm study is to compare the sensitivity and specificity of acoustic angiography with traditional b-mode ultrasound in the distinction of malignant versus benign breast lesions. Secondary objectives include a comparison of area under the curve (AUC) for acoustic angiography versus b-mode ultrasound, and comparison of radiologist preference for the two imaging techniques for each of 3 lesion characteristics.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Acoustic Angiography

Experimental

All clinical patients will be included in the experimental group.

干预措施: Acoustic Angiography (Device)

Acoustic Angiography

Experimental

All clinical patients will be included in the experimental group.

干预措施: Definity (Drug)

Image Optimization

Experimental

In addition to clinical patients, 30 participants will be recruited to aid in optimizing the imaging parameters.

干预措施: Acoustic Angiography (Device)

Image Optimization

Experimental

In addition to clinical patients, 30 participants will be recruited to aid in optimizing the imaging parameters.

干预措施: Definity (Drug)

结局指标

主要结局

Sensitivity and Specificity

时间窗: 2 years

To compare (using a reader study) the sensitivity and specificity of acoustic angiography to the sensitivity and specificity of conventional b-mode ultrasound in evaluation of breast lesions

次要结局

  • Model-based Malignancy Score (Arbitrary Units)(2 years)
  • Vessel Tortuosity (No Units)(2 years)
  • Area Under the Curve (AUC) of Acoustic Angiography(2 years)
  • Radiologist Preference(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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