NCT01928992

Brief Summary

The purpose of this pilot study is to provide credible performance estimate information in order to properly plan, design, and power a larger clinical study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 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

First Submitted

Initial submission to the registry

March 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 27, 2013

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

March 1, 2013

Last Update Submit

November 18, 2016

Conditions

Breast Cancer

Keywords

Mammography3DBreast Cancer Detection

Outcome Measures

Primary Outcomes (1)

  • Per Breast AUC

    Breast AUC performance metrics to determine if 3D has improved breast cancer detection rate as compared to 2D.

    1 Day

Secondary Outcomes (1)

  • Subject Recall Rate

    1 Day

Study Arms (2)

3D

Subjects that undergo 3D mammography

Device: 3D

2D

Subjects that undergo 2D mammography

Device: 2D

Interventions

3DDEVICE

subjects that underwent 3D mammography

3D
2DDEVICE

those subjects that underwent 2D mammography

2D

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with screening and diagnostic 3D or 2D mammography

You may qualify if:

  • Female subjects participating in prior FMSU protocol with known clinical status

You may not qualify if:

  • Subjects with unkown clinical status
  • Subjects not truthed in prior FMSU study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ACR / Image Metrix

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Carl D'Orsi, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 1, 2013

First Posted

August 27, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 21, 2016

Record last verified: 2016-11

Locations

US(1)