ShearWave™ Elastography of Breast Lesions in Chinese Patients

Breast Neoplasms Clinical Trial

— BE3  

Official title:

Assessment of ShearWave™ Elastography in the Ultrasonic Diagnosis of Breast Cancer in Chinese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226081
• Other study ID #: BE3
• Secondary ID: ChiCTR-DDT-14004
• Status: Completed
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: December 2018
• Source: SuperSonic Imagine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2273
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
SuperSonic Imagine

Country where clinical trial is conducted

China, 

References & 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 cons — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in specificity of breast ultrasound imaging when considering stiffness measurements		Within 18 months of the study start date
Secondary	Change of sensitivity and negative predictive value of breast ultrasound imaging when considering stiffness measurements		Within 18 months of the study start date
Secondary	Increase in positive predictive value for biopsy of breast ultrasound when considering stiffness measurements		within 18 months of the study start date

External Links

•   Full-length article in Cancer Management and Research journal