NCT01910103

Brief Summary

Diagnostic performance of digital breast tomosynthesis (DBT) would be not inferior to the that of breast ultrasound in women with dense breast.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
825

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

10 months

First QC Date

June 24, 2013

Last Update Submit

May 18, 2015

Conditions

Breast Neoplasms

Keywords

Breast Neoplasms/radiographyMammography/methodsMass ScreeningTomography, X-Ray Computed/methodsPredictive Value of TestsFalse Positive Reactions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance (AUC: area of under ROC curve) of DBT and US

    The primary endpoint will be an analysis of the diagnostic performance of DBT to that of US for detecting breast cancer in the screening and diagnostic setting. The hypothesis is that DBT is not inferior to US for detecting breast cancer.

    one year

Secondary Outcomes (1)

  • Diagnostic sensitivity, sensitivity, negative predictive value, and positive predictive value of DBT and US for detecting breast cancer.

    One year

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women undergoing mammography and breast US for screening or diagnostic purpose

You may qualify if:

  • Women aged at 20 years
  • Women who had heterogeneously dense or extremely dense parenchyma, either by prior mammography report or by review of prior mammograms
  • Signed study-specific informed consent prior to registration

You may not qualify if:

  • Had breast surgery
  • Had breast core biopsy performed within the prior 6 months on the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiology, Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jung Min Chang, M.D., Ph.D.

    Department of Radiology, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

June 24, 2013

First Posted

July 29, 2013

Study Start

June 1, 2013

Primary Completion

April 1, 2014

Study Completion

June 1, 2014

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

KR(1)