Spots Global Cancer Trial Database for Evaluation of the Efficacy of Digital Breast Tomosynthesis Imaging

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Trial Identification

Brief Title: Evaluation of the Efficacy of Digital Breast Tomosynthesis Imaging

Official Title: Multi-center Case Collection Study to Create a Library of Images From Various Approved FFDM Systems and 3D Images From Siemens Inspiration Digital Breast Tomosynthesis (DBT) System for Studies in Support of the Inspiration DBT Approval

Study ID: NCT01373671

Conditions

Breast Cancer

Interventions

SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM

Study Description

Brief Summary: The primary objective of this protocol is to collect the 2-dimensional (2D) screening and diagnostic images, and 3-dimensional (3D) Digital Breast Tomosynthesis (DBT) scans from patient mammography examinations acquired on various commercially available Full Field Digital Mammography (FFDM) systems and the Siemens Inspiration DBT system, respectively.

Detailed Description: The image collection includes FFDM images and both raw and presentation data from the DBT system. The FFDM mammograms are performed using standard care screening or diagnostic mammography from various commercially available FFDM systems. All DBT images are acquired on the Inspiration DBT system specifically for the study, in addition to the clinically indicated screening mammograms. DBT images are read at the clinical sites and any DBT findings were investigated according to standard care.