Clinical trial NCT01963624: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast
Screening
Ultrasound
Elastography
Doppler ultrasonography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 1241
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population will consist of asymptomatic women who visit the hospital for breast screening.

The sites are located in 4 cities of South Korea.

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 criteria: 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

Primary outcomes:
measure: Positive predictive value of breast screening with US
timeFrame: 1 year after enrollment
Secondary outcomes:
measure: Sensitivity
timeFrame: 1 year after enrollment
measure: Specificity
timeFrame: 1 year after enrollment
measure: Diagnostic accuracy
timeFrame: 1 year after enrollment
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dongnam Inst. of Radiological and Medical Sciences
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, School of Medicine, CHA University
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Seoul Metroplitan Government-Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Healthcare System Gangnam Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Woo Kyung Moon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: