Status:
COMPLETED
ShearWave™ Elastography of Breast Lesions in Chinese Patients
Lead Sponsor:
SuperSonic Imagine
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
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. Addi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
2273 Patients enrolled
Trial Details
Trial ID
NCT02226081
Start Date
June 1 2014
End Date
June 1 2015
Last Update
December 20 2018
Active Locations (22)
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1
1st Affiliated Hospital of PLAGH (304)
Beijing, China
2
Beijing Friendship Hospital, Capital Medical University
Beijing, China
3
People's Liberation Army General Hospital (301)
Beijing, China
4
Affiliated Hospital of Binzhou Medical University
Binzhou, China