此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

Ultrasound Elastography of Breast Lesions (BE1)

2013年9月2日更新者：SuperSonic Imagine

Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions

Our hypothesis is that the addition of ShearWave Elastography (SWE) to a conventional breast ultrasound examination provides useful information for the radiologist when imaging lesions in the breast, as compared to conventional grayscale ultrasound alone.

研究概览

地位

完全的

条件

乳腺肿瘤

研究类型

观察性的

注册 (实际的)

1681

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

德国
- - Greifswald、德国
    - University Hospital, Frauenklinik
  - Kiel、德国
    - University Hospital Schleswig-Holstein
  - Osnabrück、德国
    - Marienhospital, Klinik für Radiologie
  - Wiesbaden、德国
    - German Diagnostic Clinic
意大利
- - Gorizia、意大利
    - Ospedale Civile di Gorizia
法国
- - Lyon、法国
    - Hôpital privé Jean Mermoz
  - Marseille、法国
    - University hospital La Timone
  - Nice、法国
    - Centre Antoine Lacassagne
  - Paris、法国
    - Institut Curie
美国
- California
  - Los Angeles、California、美国、90033
    - University of Southern California - LAC+USC Medical Center, OPD Rm 3P61
- Colorado
  - Denver、Colorado、美国、80206
    - Sally Jobe Breast Center
- Connecticut
  - New Haven、Connecticut、美国、06510
    - Yale Medical Center, Department of Diagnostic Radiology
- Illinois
  - Chicago、Illinois、美国、60611
    - Northwestern Memorial Hospital, Dept. of Radiology
- Massachusetts
  - Boston、Massachusetts、美国、02118
    - Boston Medical Center, Radiology
- Pennsylvania
  - Philadelphia、Pennsylvania、美国、19107
    - Thomas Jefferson Medical Center, Department of Radiology
英国
- - London、英国
    - Charings Cross Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Population will consist of women who have been referred to a public or private hospital or clinic for a breast ultrasound evaluation. The sites are located various cities throughout the United States and Europe.

描述

Inclusion Criteria:

patients who have been referred to a breast ultrasound because of a positive physical palpation and/or positive mammograms and/or positive ultrasound and/or positive MRI.
female
age 21 or older
provide informed consent

Exclusion Criteria:

Women who are unwilling or unable to provide informed consent
Women with breast implants
Women with superficial lesions or lesions on skin (with the most superficial surface of the lesion within 5 mm of the skin surface)
Women who are pregnant or breastfeeding
Women who are undergoing chemotherapy or radiotherapy for any cancer
Women with previous breast conserving surgery on the breast of interest Note: Previous excision of a benign lesion 4 cm or more away from the suspected lesion does not constitute an exclusion criterion.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：仅案例
时间观点：横截面

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics 大体时间：2 years	Positive reference standard = malignant cytologic or histopathologic result. Negative reference standard = BIRADS 2 lesions, BIRADS 3 lesions with benign histopathology, or a 1 year follow-up ultrasound exam showing resolved or decreased lesion size. Conservative strategy:features of E-homogeneity, E-max and E-color were used to upgrade BIRADS 3 lesions to BIRADS 4a' or downgrade BIRADS 4a lesions to BIRADS 3'. Aggressive strategy used the same features but upgraded and downgraded more lesions. Based on 939 lesions.	2 years

次要结果测量

结果测量	措施说明	大体时间
Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature 大体时间：performed on the same day, within 2 years from study start date	614 benign and 144 malignant breast lesions were scanned in SWE 3 consecutive times, and the similarity of the 3 images was evaluated by the investigator.	performed on the same day, within 2 years from study start date
Intraobserver Reliability of Quantitative SWE Measurements 大体时间：performed on the same day, within 2 years from study start date	614 benign and 144 malignant lesions. Each category's measurement (diameter, area, etc..) is performed 3 times. These 3 measurements are then compared with each other in order to calculate the interclass correlation coefficient.	performed on the same day, within 2 years from study start date
Interobserver Agreement of B Mode Ultrasound and SWE Features 大体时间：performed on the same day, after study completion	614 benign and 144 malignant breast masses.	performed on the same day, after study completion

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

SuperSonic Imagine

调查人员

首席研究员：David O Cosgrove, MD、Hammersmith Hospitals NHS Trust

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年7月1日

初级完成 (实际的)

2010年6月1日

研究完成 (实际的)

2010年6月1日

研究注册日期

首次提交

2008年7月14日

首先提交符合 QC 标准的