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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonography | Device | Comparison of B-mode US alone and combined use of elasto-doppler US along with B-mode US. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Population will consist of asymptomatic women who visit the hospital for breast screening.
The sites are located in 4 cities of South Korea.
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| Name | Affiliation | Role |
|---|---|---|
| Woo Kyung Moon, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongnam Inst. of Radiological and Medical Sciences | Busan | South Korea | ||||
| Gyeongsang National University Hospital |
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| 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. | 1 year after enrollment |
| Jinju |
| South Korea |
| CHA Bundang Medical Center, School of Medicine, CHA University | Seongnam-si | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | South Korea |
| Gangnam Severance Hospital, Yonsei University College of Medicine | Seoul | South Korea |
| Hanyang University Medical Center | Seoul | South Korea |
| Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine | Seoul | South Korea |
| Seoul Metroplitan Government-Seoul National University Boramae Medical Center | Seoul | South Korea |
| Seoul National University Hospital Healthcare System Gangnam Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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