Spots Global Cancer Trial Database for Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound
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Trial Identification
Brief Title: Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound
Official Title: Multicenter Prospective Study to Evaluate the Value of Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound
Study ID: NCT01963624
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age: 30 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
Dongnam Inst. of Radiological and Medical Sciences, Busan, , Korea, Republic of
Gyeongsang National University Hospital, Jinju, , Korea, Republic of
CHA Bundang Medical Center, School of Medicine, CHA University, Seongnam-si, , Korea, Republic of
Ewha Womans University Mokdong Hospital, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, , Korea, Republic of
Hanyang University Medical Center, Seoul, , Korea, Republic of
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 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
Contact Details
Name: Woo Kyung Moon, M.D., Ph.D.
Affiliation: Seoul National University Hospital
Role: PRINCIPAL_INVESTIGATOR
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