NCT02226081CompletedNot Applicable
Assessment of ShearWave™ Elastography in the Ultrasonic Diagnosis of Breast Cancer in Chinese Patients
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- SuperSonic Imagine
- Enrollment
- 2,273
- Locations
- 22
- Primary Endpoint
- Increase in specificity of breast ultrasound imaging when considering stiffness measurements
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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
Outcomes
Primary Outcomes
Increase in specificity of breast ultrasound imaging when considering stiffness measurements
Time Frame: Within 18 months of the study start date
Secondary Outcomes
- 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)
Investigators
Study Sites (22)
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