Trial Outcomes & Findings for Multicenter Hologic Tomosynthesis Study (NCT NCT00971087)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3521 participants

Primary outcome timeframe

At time of exam

Results posted on

2025-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects Undergoing Breast Cancer Screening The study population included both women undergoing routing annual mammography imaging and women undergoing a previously scheduled breast biopsy. 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
Overall Study STARTED	3521
Overall Study COMPLETED	3521
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multicenter Hologic Tomosynthesis Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Undergoing Breast Cancer Screening n=3521 Participants The study population included both women undergoing routing annual mammography imaging and women undergoing a previously scheduled breast biopsy. 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3000 Participants n=5 Participants
Age, Categorical >=65 years	521 Participants n=5 Participants
Sex: Female, Male Female	3521 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	3521 participants n=5 Participants

PRIMARY outcome

Timeframe: At time of exam

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

Outcome measures

Outcome measures
Measure	3D + s2D n=302 Participants Investigational Image Set: Three Dimensional breast tomosynthesis images with a synthesized 2D image (3D + s2D)	2D FFDM n=302 Participants Two Dimensional full-field digital mammography (2D FFDM)
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.	0.907 Proportion Interval 0.887 to 0.925	0.867 Proportion Interval 0.81 to 0.899

SECONDARY outcome

Timeframe: At time of exam

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.

Outcome measures

Outcome measures
Measure	3D + s2D n=148 Participants Investigational Image Set: Three Dimensional breast tomosynthesis images with a synthesized 2D image (3D + s2D)	2D FFDM n=148 Participants Two Dimensional full-field digital mammography (2D FFDM)
Analysis of ROC Performance in Subjects With Dense Breasts	0.893 Proportion Interval 0.859 to 0.929	0.848 Proportion Interval 0.803 to 0.901

SECONDARY outcome

Timeframe: at time of exam

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

Outcome measures

Outcome measures
Measure	3D + s2D n=76 Participants Investigational Image Set: Three Dimensional breast tomosynthesis images with a synthesized 2D image (3D + s2D)	2D FFDM n=76 Participants Two Dimensional full-field digital mammography (2D FFDM)
Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM	54.6 percentage of recalls	67.2 percentage of recalls

Adverse Events

Subjects Undergoing Breast Cancer Screening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Bartoshevich, Sr Manager of Clinical Affairs

Hologic

Phone: 781-999-7764

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60