ShearWave™ Elastography of Breast Lesions in Chinese Patients
Conditions
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
breast lesion, ultrasound, BI-RADS, women, malignancy
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Overall Status
Recruiting
Summary
We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can improve the characterization (classification) of breast lesions.
Detailed Description
Chinese women are known to have denser breasts than women in Western countries. Mammography cannot find abnormalities easily in denser breasts, while breast ultrasound is not affected by density. Adding elastography, a stiffness measurement, to a breast ultrasound exam should improve the diagnosis of a lesion.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- female

- 18 years of age or older

- known breast lesion that has not been managed or treated

- referred for a breast ultrasound because of a breast mass found on at least one of the following examinations:

- physical palpation

- mammography

- ultrasound exam

- MRI

Exclusion Criteria:

- Women who are unwilling or unable to provide informed consent

- Women with breast implants

- Women who are pregnant or breastfeeding

- Women in whom all lesions are diagnostically categorized as BI-RADS 0, 1 or 6

- Women with previous ipsilateral breast surgery

- Women with no visible breast mass on ultrasound examination

- Women with axillary metastatic lymph nodes only

- Women with foreign body in the breast

- Women who are not Chinese nationality
Locations
1st Affiliated Hospital of PLAGH (304)
Beijing, China
Status: Recruiting
Contact: Chaoyang Wen - wency301@vip.sina.com
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Status: Recruiting
Contact: Linxue Qian - qqianlinxue2002@163.com
People's Liberation Army General Hospital (301)
Beijing, China
Status: Recruiting
Contact: Junlai Li - li_jl@yeah.net
Affiliated Hospital of Binzhou Medical University
Binzhou, China
Status: Recruiting
Contact: Guanghe Cui - 13061030808@163.com
Sichuan Provincial People's Hospital
Chengdu, China
Status: Recruiting
Contact: Qin Chen - chenqin630528@sina.com
West China Hospital, Sichuan University
Chengdu, China
Status: Recruiting
Contact: Yulan Peng - yulanpeng@sohu.com
Fujian Provincial Cancer Hospital
Fuzhou, China
Status: Recruiting
Contact: Lina Tang - 407062881@qq.com
Guangdong Provincial Traditional Chinese Medical Hospital
Guangzhou, China
Status: Recruiting
Contact: Jianxing Zhang - venant@126.com
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, China
Status: Recruiting
Contact: Baoming Luo - bmluo2005@126.com
Sun-Yat Sen University Cancer Center
Guangzhou, China
Status: Recruiting
Contact: Anhua Li - lianhua58@126.com
1st Affiliated Hospital of Harbin University
Harbin, China
Status: Recruiting
Contact: Changjun Wu - 116925001@qq.com
Hefei 2nd People's Hospital
Hefei, China
Status: Recruiting
Contact: Xiao Yang - yx6081@126.com
Jiangsu Provincial Hospital
Nanjing, China
Status: Recruiting
Contact: Hongjun Lin - linhongjun0909@163.com
Yinzhou People's Hospital
Ningbo, China
Status: Recruiting
Contact: Ruhai Zhou - zhrh1111@yahoo.com.cn
Fudan University Cancer Center
Shanghai, China
Status: Recruiting
Contact: Cai Chang - changcai@sina.com
1st Affiliated Hospital of China Medical University
Shenyang, China
Status: Recruiting
Contact: Xuemei Wang - wxmlmt@163.com
4th Affiliated Hospital of China Medical University
Shenyang, China
Status: Recruiting
Contact: Lingzhi Ma - malingzhi601215@126.com
Shengjing Hospital of China Medical University
Shenyang, China
Status: Recruiting
Contact: Weidong Ren - renweidong@sj-hospital.com
General Hospital of TISCO
Taiyuan, China
Status: Recruiting
Contact: Quanbin Zhang - tgzyyzqb@sohu.com
Shanxi Dayi Hospital
Taiyuan, China
Status: Recruiting
Contact: Chunsong Kang - kangchunsong2005@sina.com
1st Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Status: Recruiting
Contact: Hong Ai - hong-ai@163.com
1st Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Status: Recruiting
Contact: Jianmin Chang - 1878768385@qq.com
Start Date
June 2014
Completion Date
December 2015
Sponsors
SuperSonic Imagine
Source
SuperSonic Imagine
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page