Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound

N/ACompletedNCT01963624

Seoul National University Hospital1,241 enrolled

Overview

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

* 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.

Study Type

OBSERVATIONAL

Enrollment

1,241

Conditions

Breast Cancer

Interventions

UltrasonographyDEVICE

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

Eligibility

Sex: FEMALEMin age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (10)

Dongnam Inst. of Radiological and Medical Sciences

Busan, South Korea

Gyeongsang National University Hospital

Jinju, South Korea

CHA Bundang Medical Center, School of Medicine, CHA University

Seongnam-si, South Korea

Outcomes

Primary Outcomes

Positive predictive value of breast screening with US

Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.

Time frame: 1 year after enrollment

Secondary Outcomes

Sensitivity

Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.

Time frame: 1 year after enrollment

Specificity

Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.

Time frame: 1 year after enrollment

Diagnostic accuracy

Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy.

Time frame: 1 year after enrollment

Data from ClinicalTrials.gov

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