ShearWave™ Elastography of Breast Lesions in Chinese Patients

Completed

• Conditions: Breast Neoplasms

• Registration Number: NCT02226081
• Lead Sponsor: SuperSonic Imagine

Brief 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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-08-25
• Study First Submitted QC: 2014-08-25
• Study First Posted: 2014-08-26
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2273

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in specificity of breast ultrasound imaging when considering stiffness measurements	Within 18 months of the study start date

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (22)

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, China

Fujian Provincial Cancer Hospital; 🇨🇳 Fuzhou, China

1st Affiliated Hospital of PLAGH (304); 🇨🇳 Beijing, China

People's Liberation Army General Hospital (301); 🇨🇳 Beijing, China

1st Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China

Fudan University Cancer Center; 🇨🇳 Shanghai, China

4th Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, China

Hefei 2nd People's Hospital; 🇨🇳 Hefei, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, China

Yinzhou People's Hospital; 🇨🇳 Ningbo, China

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, China

General Hospital of TISCO; 🇨🇳 Taiyuan, China

Shanxi Dayi Hospital; 🇨🇳 Taiyuan, China

Jiangsu Provincial Hospital; 🇨🇳 Nanjing, China

1st Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, China

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, China

Affiliated Hospital of Binzhou Medical University; 🇨🇳 Binzhou, 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

1st Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, China