Multicenter Hologic Tomosynthesis Study

February 5, 2025 updated by: Hologic, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3521

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Scottsdale Medical Imaging Ltd. (SMIL)
    • California
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital
      • Sacramento, California, United States, 95817
        • UC Davis
    • Colorado
      • Greenwood Village, Colorado, United States, 80111
        • Invision/Sally Jobe
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Community Hospital
      • Hollywood, Florida, United States, 33021
        • Memorial Florida
    • Illinois
      • Chicago, Illinois, United States, 60068
        • Luthern General - Advocate Health Care
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes Jewish
    • New York
      • Rochester, New York, United States, 14620
        • Elizabeth Wende Breast Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 45912
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee Women's Hospital
      • York, Pennsylvania, United States, 17403
        • York - Women's Imaging at Apple Hill
    • Texas
      • Dallas, Texas, United States, 75039
        • UTSW Center for Breast Care
      • Houston, Texas, United States, 77074
        • Memorial Hermann/ Memorial City
    • Utah
      • Murray, Utah, United States, 84175
        • Intermountain Medical Imaging
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Subjects undergoing breast cancer screening
The study population included both women undergoing routing annual mammography imaging and women undergoing a previously scheduled breast biopsy
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.
Other Names:
  • Selenia Dimensions
  • Tomosynthesis
  • Tomo
  • Breast tomosynthesis
  • 3D Breast imaging
  • 2D plus 3D breast imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
At time of exam

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of ROC Performance in Subjects With Dense Breasts
Time Frame: 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.
At time of exam
Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM
Time Frame: at time of exam
The non-cancer recall rate was measured for 3DS and 2D FFDM
at time of exam

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hologic, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 2, 2009

First Submitted That Met QC Criteria

September 2, 2009

First Posted (Estimated)

September 3, 2009

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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