Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound

Multicenter Prospective Study to Evaluate the Value of Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound

The investigators hypothesis is that the combined use of elastography and color doppler ultrasonography can increase positive-predictive value of breast screening with ultrasound.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Ultrasonography

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.

• Study Type: Observational
• Enrollment (Actual): 1241

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Dongnam Inst. of Radiological and Medical Sciences
  • Jinju, Korea, Republic of
    • Gyeongsang National University Hospital
  • Seongnam-si, Korea, Republic of
    • CHA Bundang Medical Center, School of Medicine, CHA University
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of
    • Hanyang University Medical Center
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital, Yonsei University College of Medicine
  • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Ultrasonography; Comparison of B-mode US alone and combined use of elasto-doppler US along with B-mode US.; Other Names: Aixplorer system (SuperSonic Imagine, France); EUB-series/HV-ASCENDUS (Hitachi Medical, Japan)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Woo Kyung Moon, M.D., Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: October 13, 2013
• First Submitted That Met QC Criteria: October 15, 2013
• First Posted (Estimate): October 16, 2013

Study Record Updates

• Last Update Posted (Estimate): April 20, 2016
• Last Update Submitted That Met QC Criteria: April 18, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Ultrasound; Screening; Elastography; Breast; Doppler ultrasonography
• Other Study ID Numbers: Elasto-Doppler Ultrasonography