NCT00971087

Multicenter Hologic Tomosynthesis Study

A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,521 (actual)
• Sponsor: Hologic, Inc. · Industry
• Sex: Female
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this image acquisition study is to compare, in a Reader Study, the performance of Tomosynthesis (3D) to (2D FFDM) conventional images in an enriched retrospective reader study. Synthetic 2D images, generated from the tomosynthesis image, will be available to the readers to provide an over view of the anatomy similar to a scout view in CT imaging and to determine whether the 3-D images with the synthesized 2D overview are non-inferior to the 2-D images alone as determined by receiver operating characteristic (ROC) area under the curve.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Hologic Selenia Dimensions Digital Breast Tomosynthesis System	Subjects are exposed to the same number of investigational images collected on the investigational device (Selenia Dimensions Full Field Digital Mammography System). Subject enrollment occurs at the time subjects are being imaged for their standard of care mammographic work up (either screening mammogram or scheduled biopsy). All subjects undergoing a biopsy procedure will be imaged on the investigational device prior to their procedure.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-09-01
• Completion: 2012-04-01
• First posted: 2009-09-03
• Last updated: 2025-02-26
• Results posted: 2025-02-26

Locations

22 sites across 1 country: United States