Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound
- Conditions
- Breast Cancer
- Interventions
- Device: Ultrasonography
- Registration Number
- NCT01963624
- Lead Sponsor
- Seoul National University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1241
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Breast masses detected with screening US Ultrasonography Those assessed with conventional B-mode US alone and those assessed with combined elastography and color doppler ultrasonography along with B-mode US.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (10)
Dongnam Inst. of Radiological and Medical Sciences
🇰🇷Busan, Korea, Republic of
Gyeongsang National University Hospital
🇰🇷Jinju, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
CHA Bundang Medical Center, School of Medicine, CHA University
🇰🇷Seongnam-si, Korea, Republic of
Gangnam Severance Hospital, Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of
Hanyang University Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul Metroplitan Government-Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital Healthcare System Gangnam Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
🇰🇷Seoul, Korea, Republic of