Multicenter Hologic Tomosynthesis Study

Hologic, Inc.3,521 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

3,521

Conditions

Breast Cancer

Interventions

Hologic Selenia Dimensions Digital Breast Tomosynthesis SystemDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 110 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female * Any ethnic origin * No contraindication of routine bilateral mammography Exclusion Criteria: * Any contraindications to mammographic screening, including but not limited to: * Significant existing breast trauma * Pregnancy * Lactating * Previous surgical biopsy * Previous breast cancer * Placement of an internal breast marker * Breast implants * Unable to understand and execute written informed consent * Breasts are too large to be imaged on the 24 cm by 29 cm detector with a single exposure

Locations (22)

Scottsdale Medical Imaging Ltd. (SMIL)

Scottsdale, Arizona, United States

Outcomes

Primary Outcomes

To Demonstrate Non-inferior ROC Performance as Measured by the Area Under the Curve When Comparing 3-Ds Plus 3-D Images to the 2-D Images.

ROC performance as measured by the area under the curve when comparing 3-Ds plus 3-D images to the 2-D images.

Time frame: At time of exam

Secondary Outcomes

Analysis of ROC Performance in Subjects With Dense Breasts

The radiologist's POM case based score will be used to generate the 2D FFDM and 3DS ROC curves for women with dense breasts (defined as BIRADS density score of 3 or 4). Endpoint Analysis - A multi-reader, multi-case ROC analysis will be used to compare 3DS to 2D FFDM. The areas under the curve (AUC) will be used to compare ROC performance. 3DS will be considered non-inferior to 2D FFDM if the lower limit one-sided 95% CI for the difference in AUCs (3DS minus 2D FFDM) is greater than -0.05. A difference of 0.05 is considered a clinically significant difference.

Time frame: At time of exam

Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM

The non-cancer recall rate was measured for 3DS and 2D FFDM

Time frame: at time of exam

Data from ClinicalTrials.gov

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