NCT00990483

A Comparison of the 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography for Breast Abnormalities

A Comparison of 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography in the Visualization and Characterization of Breast Abnormalities

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Hologic, Inc. · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to conduct an initial investigation into whether an alternative method of using 3D imaging might offer accurate diagnostic performance at a reduced patient radiation exposure in comparison to conventional 2D screening and diagnostic mammography and conventional 2D + 3D imaging methods.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	3D mammograpgy system	In addition to the standard care diagnostic imaging, all participants underwent two experimental acquisitions, in two projections (Cranio-Caudal and Mediolateral Oblique) on the breast of concern: one acquisition in Mode A (narrow angle acquisition) and one acquisition in Mode B (wide angle acquisition). The experimental imaging is compared to the standard of care imaging

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-09-01
• Completion: 2010-10-01
• First posted: 2009-10-06
• Last updated: 2024-02-29

Locations

1 site across 1 country: United States