Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1241 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-01-31

Brief Summary

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The investigators hypothesis is that the combined use of elastography and color doppler ultrasonography can increase positive-predictive value of breast screening with ultrasound.

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Detailed Description

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* Asymptomatic women who undergo breast screening with ultrasound and has breast masses of Breast Imaging Reporting and Data System (BI-RADS) category 3 or higher will be examined with conventional B-mode US as well as combined elasto-doppler US by breast radiologists.
* The likelihood of malignancy and BI-RADS category of the breast masses are assessed for each dataset of B-mode US alone and B-mode US with elasto-doppler US, respectively.
* Reference standard: Biopsy or 1 year of follow-up examination.
* The positive-predictive value, sensitivity, specificity, and diagnostic accuracy (assessed by the area under the receiver operating characteristic curve) are evaluated and compared between B-mode US alone and B-mode US with elasto-doppler US.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Breast masses detected with screening US

Those assessed with conventional B-mode US alone and those assessed with combined elastography and color doppler ultrasonography along with B-mode US.

Ultrasonography

Intervention Type DEVICE

Comparison of B-mode US alone and combined use of elasto-doppler US along with B-mode US.

Interventions

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Ultrasonography

Comparison of B-mode US alone and combined use of elasto-doppler US along with B-mode US.

Intervention Type DEVICE

Other Intervention Names

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Aixplorer system (SuperSonic Imagine, France) EUB-series/HV-ASCENDUS (Hitachi Medical, Japan)

Eligibility Criteria

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Inclusion Criteria

* Women aged 30 years or older screened with breast ultrasound without specific symptoms
* Women who underwent mammography within 3 months which showed no abnormality except for dense breast
* Women who had at least one breast mass of BI-RADS category 3 or higher.

Exclusion Criteria

* Women with breast implants
* Women who are unwilling or unable to provide informed consent
* Lesions larger than 3 cm
* Lesions that are previously noted and followed-up in the same hospital

Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes