Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound

April 18, 2016 updated by: Woo Kyung Moon, Seoul National University Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 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.
1 year after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: 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.
1 year after enrollment
Specificity
Time Frame: 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.
1 year after enrollment
Diagnostic accuracy
Time Frame: 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.
1 year after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • Elasto-Doppler Ultrasonography

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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