NCT01963624

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,241

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

2.2 years

First QC Date

October 13, 2013

Last Update Submit

April 18, 2016

Conditions

Breast Cancer

Keywords

BreastScreeningUltrasoundElastographyDoppler ultrasonography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Sensitivity

    1 year after enrollment

  • Specificity

    1 year after enrollment

  • Diagnostic accuracy

    1 year after enrollment

Study Arms (1)

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

Interventions

UltrasonographyDEVICE

Comparison of B-mode US alone and combined use of elasto-doppler US along with B-mode US.

Also known as: Aixplorer system (SuperSonic Imagine, France), EUB-series/HV-ASCENDUS (Hitachi Medical, Japan)
Breast masses detected with screening US

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Dongnam Inst. of Radiological and Medical Sciences

Busan, South Korea

Location

Gyeongsang National University Hospital

Jinju, South Korea

Location

CHA Bundang Medical Center, School of Medicine, CHA University

Seongnam-si, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Gangnam Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Location

Hanyang University Medical Center

Seoul, South Korea

Location

Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine

Seoul, South Korea

Location

Seoul Metroplitan Government-Seoul National University Boramae Medical Center

Seoul, South Korea

Location

Seoul National University Hospital Healthcare System Gangnam Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Woo Kyung Moon, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 13, 2013

First Posted

October 16, 2013

Study Start

November 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

KR(10)