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

December 18, 2018 updated by: SuperSonic Imagine

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

2273

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Friendship Hospital, Capital Medical University
      • Beijing, China
        • 1st Affiliated Hospital of PLAGH (304)
      • Beijing, China
        • People's Liberation Army General Hospital (301)
      • Binzhou, China
        • Affiliated Hospital of Binzhou Medical University
      • Chengdu, China
        • West China Hospital, Sichuan University
      • Chengdu, China
        • Sichuan Provincial People's Hospital
      • Fuzhou, China
        • Fujian Provincial Cancer Hospital
      • Guangzhou, China
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Guangzhou, China
        • Guangdong Provincial Traditional Chinese Medical Hospital
      • Guangzhou, China
        • Sun-Yat Sen University Cancer Center
      • Harbin, China
        • 1st Affiliated Hospital of Harbin University
      • Hefei, China
        • Hefei 2nd People's Hospital
      • Nanjing, China
        • Jiangsu Provincial Hospital
      • Ningbo, China
        • Yinzhou People's Hospital
      • Shanghai, China
        • Fudan University Cancer Center
      • Shenyang, China
        • Shengjing Hospital of China Medical University
      • Shenyang, China
        • 1st Affiliated Hospital of China Medical University
      • Shenyang, China
        • 4th Affiliated Hospital of China Medical University
      • Taiyuan, China
        • General Hospital of TISCO
      • Taiyuan, China
        • Shanxi Dayi Hospital
      • Xi'an, China
        • 1st Affiliated Hospital of Xi'an Jiaotong University
      • Zhengzhou, China
        • 1st Affiliated Hospital of Zhengzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase in specificity of breast ultrasound imaging when considering stiffness measurements
Time Frame: Within 18 months of the study start date
Within 18 months of the study start date

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Within 18 months of the study start date
Increase in positive predictive value for biopsy of breast ultrasound when considering stiffness measurements
Time Frame: within 18 months of the study start date
within 18 months of the study start date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SuperSonic Imagine

Investigators

  • Principal Investigator: Cai Chang, Fudan University
  • Principal Investigator: Anhua Li, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

August 25, 2014

First Posted (Estimate)

August 26, 2014

Study Record Updates

Last Update Posted (Actual)

December 20, 2018

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE3
  • ChiCTR-DDT-14004785 (Registry Identifier: China Clinical Trial)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe