ShearWave™ Elastography of Breast Lesions in Chinese Patients
BE3
Assessment of ShearWave™ Elastography in the Ultrasonic Diagnosis of Breast Cancer in Chinese Patients
2 other identifiers
observational
2,273
1 country
22
Brief Summary
We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can improve the characterization (classification) of breast lesions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2014
Shorter than P25 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 25, 2014
CompletedFirst Posted
Study publicly available on registry
August 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedDecember 20, 2018
December 1, 2018
1 year
August 25, 2014
December 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increase in specificity of breast ultrasound imaging when considering stiffness measurements
Within 18 months of the study start date
Secondary Outcomes (2)
Change of sensitivity and negative predictive value of breast ultrasound imaging when considering stiffness measurements
Within 18 months of the study start date
Increase in positive predictive value for biopsy of breast ultrasound when considering stiffness measurements
within 18 months of the study start date
Eligibility Criteria
Chinese women (age of majority) who have been referred to a hospital or clinical for a breast ultrasound evaluation.
You may qualify if:
- female
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
1st Affiliated Hospital of PLAGH (304)
Beijing, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
People's Liberation Army General Hospital (301)
Beijing, China
Affiliated Hospital of Binzhou Medical University
Binzhou, China
Sichuan Provincial People's Hospital
Chengdu, China
West China Hospital, Sichuan University
Chengdu, China
Fujian Provincial Cancer Hospital
Fuzhou, China
Guangdong Provincial Traditional Chinese Medical Hospital
Guangzhou, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, China
Sun-Yat Sen University Cancer Center
Guangzhou, China
1st Affiliated Hospital of Harbin University
Harbin, China
Hefei 2nd People's Hospital
Hefei, China
Jiangsu Provincial Hospital
Nanjing, China
Yinzhou People's Hospital
Ningbo, China
Fudan University Cancer Center
Shanghai, China
1st Affiliated Hospital of China Medical University
Shenyang, China
4th Affiliated Hospital of China Medical University
Shenyang, China
Shengjing Hospital of China Medical University
Shenyang, China
General Hospital of TISCO
Taiyuan, China
Shanxi Dayi Hospital
Taiyuan, China
1st Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
1st Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Related Publications (1)
Lin X, Chang C, Wu C, Chen Q, Peng Y, Luo B, Tang L, Li J, Zheng J, Zhou R, Cui G, Li A, Wang X, Qian L, Zhang J, Wen C, Gay J, Zhang H, Li A, Chen Y. Confirmed value of shear wave elastography for ultrasound characterization of breast masses using a conservative approach in Chinese women: a large-size prospective multicenter trial. Cancer Manag Res. 2018 Oct 11;10:4447-4458. doi: 10.2147/CMAR.S174690. eCollection 2018.
PMID: 30349377RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cai Chang
Fudan University
- PRINCIPAL INVESTIGATOR
Anhua Li
Sun Yat-sen University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2014
First Posted
August 26, 2014
Study Start
June 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
December 20, 2018
Record last verified: 2018-12