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

FujiFilm

Status: Completed

Conditions: Breast Cancer

Treatments: Device: 3D; Device: 2D

Study type: Observational

Funder types: Industry

Identifiers

NCT01928992

FMSU2011-003B

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

3D

Description:

Subjects that undergo 3D mammography

Treatment:

Device: 3D

2D

Description:

Subjects that undergo 2D mammography

Treatment:

Device: 2D