NCT01542814

Collection of FUJIFILM's 3Dimensional Mammograms

Acquisition of Mammography Images for Clinical Evaluation of FUJIFILM 3Dimensional Mammography

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 600 (actual)
• Sponsor: Fujifilm Medical Systems USA, Inc. · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

This image-acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. The acquired data will be used to support FUJIFILM protocol FMSU2011-003B (Clinical Evaluation of FUJIFILM 3Dimensional Digital Mammography) and future regulatory submissions.

Detailed description

This is an image acquisition reader study to observe differences between 3D FujiFilm Mammography and 2D approved Mammography

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	3Dimensional Mammography	The FUJIFILM 3DM examination is a 4-view mammogram which includes CC and MLO views of each breast. For each view, a routine (0-degree) mammogram will be acquired followed immediately in the same compression by a second mammogram offset at 4 degrees.
DEVICE	2D FFDM	Standard of care screening mammogram.

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-03-02
• Last updated: 2013-10-25

Locations

3 sites across 1 country: United States