NCT01569802

Brief Summary

The primary aim of this study is to measure, document and compare recall rates of two-dimensional plus three dimensional (2D plus 3D) (Tomosynthesis) mammography to that of 2D mammography in a screening population. This study will compare recall rates for both non-cancer and cancer cases.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
Last Updated

April 3, 2012

Status Verified

March 1, 2012

First QC Date

March 29, 2012

Last Update Submit

March 30, 2012

Conditions

Breast Cancer

Keywords

breast cancer screeningtomosynthesisFFDM

Outcome Measures

Primary Outcomes (1)

  • Recall Rate

    measure, document and compare recall rates of two-dimensional plus three dimensional (2D plus 3D) (Tomosynthesis) mammography to that of 2D mammography in a screening population

    up to 1 year

Secondary Outcomes (1)

  • Cancer detection Rate

    up to 1 year

Study Arms (1)

screening

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

radiology clinic screening population

You may qualify if:

  • Subject is female of any race and ethnicity
  • The subject is asymptomatic and presents for routine screening mammography and chooses to have a combination 2D + 3D mammogram as her standard of care.

You may not qualify if:

  • Patient chooses standard 2D mammography over a combination 2D + 3D mammogram

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TOPS

Houston, Texas, 77090, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2012

First Posted

April 3, 2012

Study Start

January 1, 2012

Last Updated

April 3, 2012

Record last verified: 2012-03

Locations

US(1)