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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SuperSonic Imagine
ClinicalTrials.gov Identifier:
NCT02226081
First received: August 25, 2014
Last updated: April 18, 2016
Last verified: April 2016
  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 ]

Enrollment: 2273
Study Start Date: June 2014
Study Completion Date: June 2015
Primary Completion Date: June 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   (Adult, Senior)
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

Locations
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, China
Sponsors and Collaborators
SuperSonic Imagine
Investigators
Principal Investigator: Cai Chang Fudan University
Principal Investigator: Anhua Li Sun Yat-sen University
  More Information

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: April 18, 2016
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 28, 2016