ShearWave™ Elastography of Breast Lesions in Chinese Patients (BE3)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by SuperSonic Imagine
Sponsor:
Information provided by (Responsible Party):
SuperSonic Imagine
ClinicalTrials.gov Identifier:
NCT02226081
First received: August 25, 2014
Last updated: May 11, 2015
Last verified: May 2015
  Purpose

We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can improve the characterization (classification) of breast lesions.


Condition
Breast Neoplasms

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assessment of ShearWave™ Elastography in the Ultrasonic Diagnosis of Breast Cancer in Chinese Patients

Resource links provided by NLM:


Further study details as provided by SuperSonic Imagine:

Primary Outcome Measures:
  • Increase in specificity of breast ultrasound imaging when considering stiffness measurements [ Time Frame: Within 18 months of the study start date ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of sensitivity and negative predictive value of breast ultrasound imaging when considering stiffness measurements [ Time Frame: Within 18 months of the study start date ] [ Designated as safety issue: No ]
  • Increase in positive predictive value for biopsy of breast ultrasound when considering stiffness measurements [ Time Frame: within 18 months of the study start date ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: June 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Chinese women (age of majority) who have been referred to a hospital or clinical for a breast ultrasound evaluation.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02226081

Contacts
Contact: Joel Gay joel.gay@supersonicimagine.com
Contact: Holly Zheng holly.zheng@supersonicimagine.com

Locations
China
1st Affiliated Hospital of PLAGH (304) Recruiting
Beijing, China
Contact: Chaoyang Wen       wency301@vip.sina.com   
Principal Investigator: Chaoyang Wen         
Beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Linxue Qian       qqianlinxue2002@163.com   
Principal Investigator: Linxue Qian         
People's Liberation Army General Hospital (301) Recruiting
Beijing, China
Contact: Junlai Li       li_jl@yeah.net   
Principal Investigator: Junlai Li         
Affiliated Hospital of Binzhou Medical University Recruiting
Binzhou, China
Contact: Guanghe Cui       13061030808@163.com   
Principal Investigator: Guanghe Cui         
Sichuan Provincial People's Hospital Recruiting
Chengdu, China
Contact: Qin Chen       chenqin630528@sina.com   
Principal Investigator: Qin Chen         
West China Hospital, Sichuan University Recruiting
Chengdu, China
Contact: Yulan Peng       yulanpeng@sohu.com   
Principal Investigator: Yulan Peng         
Fujian Provincial Cancer Hospital Recruiting
Fuzhou, China
Contact: Lina Tang       407062881@qq.com   
Principal Investigator: Lina Tang         
Guangdong Provincial Traditional Chinese Medical Hospital Recruiting
Guangzhou, China
Contact: Jianxing Zhang       venant@126.com   
Principal Investigator: Jianxing Zhang         
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Recruiting
Guangzhou, China
Contact: Baoming Luo       bmluo2005@126.com   
Principal Investigator: Baoming Luo         
Sun-Yat Sen University Cancer Center Recruiting
Guangzhou, China
Contact: Anhua Li       lianhua58@126.com   
Principal Investigator: Anhua Li         
1st Affiliated Hospital of Harbin University Recruiting
Harbin, China
Contact: Changjun Wu       116925001@qq.com   
Principal Investigator: Changjun Wu         
Hefei 2nd People's Hospital Recruiting
Hefei, China
Contact: Xiao Yang       yx6081@126.com   
Principal Investigator: Xiao Yang         
Jiangsu Provincial Hospital Recruiting
Nanjing, China
Contact: Hongjun Lin       linhongjun0909@163.com   
Principal Investigator: Hongjun Lin         
Yinzhou People's Hospital Recruiting
Ningbo, China
Contact: Ruhai Zhou       zhrh1111@yahoo.com.cn   
Principal Investigator: Ruhai Zhou         
Fudan University Cancer Center Recruiting
Shanghai, China
Contact: Cai Chang       changcai@sina.com   
Principal Investigator: Cai Chang         
1st Affiliated Hospital of China Medical University Recruiting
Shenyang, China
Contact: Xuemei Wang       wxmlmt@163.com   
Principal Investigator: Xuemei Wang         
4th Affiliated Hospital of China Medical University Recruiting
Shenyang, China
Contact: Lingzhi Ma       malingzhi601215@126.com   
Principal Investigator: Lingzhi Ma         
Shengjing Hospital of China Medical University Recruiting
Shenyang, China
Contact: Weidong Ren       renweidong@sj-hospital.com   
Principal Investigator: Weidong Ren         
General Hospital of TISCO Recruiting
Taiyuan, China
Contact: Quanbin Zhang       tgzyyzqb@sohu.com   
Principal Investigator: Quanbin Zhang         
Shanxi Dayi Hospital Recruiting
Taiyuan, China
Contact: Chunsong Kang       kangchunsong2005@sina.com   
Principal Investigator: Chunsong Kang         
1st Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, China
Contact: Hong Ai       hong-ai@163.com   
Principal Investigator: Hong Ai         
1st Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, China
Contact: Jianmin Chang       1878768385@qq.com   
Principal Investigator: Jianmin Chang         
Sponsors and Collaborators
SuperSonic Imagine
Investigators
Principal Investigator: Cai Chang Fudan University
Principal Investigator: Anhua Li Sun Yat-sen University
  More Information

No publications provided

Responsible Party: SuperSonic Imagine
ClinicalTrials.gov Identifier: NCT02226081     History of Changes
Other Study ID Numbers: BE3, ChiCTR-DDT-14004785
Study First Received: August 25, 2014
Last Updated: May 11, 2015
Health Authority: China: Ethics Committee

Keywords provided by SuperSonic Imagine:
breast lesion
ultrasound
BI-RADS
women
malignancy

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2015