Pilot 3D Mammography Reader Study to Assess Breast Cancer Detection in 3D Versus 2D Digital Mammography

A Multi-reader, Multi-case, Controlled Clinical Trial to Evaluate the Fuji Film 3D Digital Mammography System Used in Conjunction With 2D Digital Mammography in the Detection of Breast Cancer / A Pilot Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01928992

Acronym

3DM

Enrollment

100

Registered

2013-08-27

Start date

2013-03-31

Completion date

2013-06-30

Last updated

2016-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Mammography, 3D, Breast Cancer Detection

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.

Interventions

DEVICE3D

subjects that underwent 3D mammography

DEVICE2D

those subjects that underwent 2D mammography

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Per Breast AUC	1 Day	Breast AUC performance metrics to determine if 3D has improved breast cancer detection rate as compared to 2D.

Secondary

Measure	Time frame	Description
Subject Recall Rate	1 Day	For Cancer and Non-Cancer Cases to determine if 3D can reduce the need for follow-up mammography and/or improve time to determination of need for a biopsy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026