Breast Cancer
Conditions
Keywords
Breast, Screening, Ultrasound, Elastography, Doppler ultrasonography
Brief summary
The investigators hypothesis is that the combined use of elastography and color doppler ultrasonography can increase positive-predictive value of breast screening with ultrasound.
Detailed description
* 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.
Interventions
DEVICEUltrasonography
Comparison of B-mode US alone and combined use of elasto-doppler US along with B-mode US.
Sponsors
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive predictive value of breast screening with US | 1 year after enrollment | Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | 1 year after enrollment | Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy. |
| Specificity | 1 year after enrollment | Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy. |
| Diagnostic accuracy | 1 year after enrollment | Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy. |
Countries
South Korea
Outcome results
None listed