Evaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography

August 9, 2022 updated by: Hologic, Inc.

A Multicenter, Controlled Clinical Trial to Evaluate the Hologic 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography

This was a multi-center, prospective clinical trial in which the subject was her own control. Approximately 950-1400 female subjects were enrolled at five (5) sites in the United States. Subjects were from either a Screening population or a biopsy population and were imaged first on a conventional 2D full filed digital mammography system then on a 3D tomosynthesis system.

The resulting images from the this portion of the study were then randomized into a reader study.

The purpose of this clinical study was to compare the 3-D tomosynthesis system used in conjunction with a conventional 2-D digital imaging system (2-D plus 3-D images) to the conventional 2-D digital imaging system (2-D images), and to determine whether the 2-D plus 3-D images compared to the 2-D images alone would:

  1. Reduce the recall rate And/or
  2. Improve ROC area due to improved breast cancer detection and/or improved lesion classification.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1183

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
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale New Haven Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02116
        • Massachusetts General Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee Women's Hospital

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

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Any ethnic origin
  • No contraindication for screening mammography

Exclusion Criteria:

  • Significant breast trauma
  • Pregnancy
  • Lactating
  • Breast implants
  • Previous breast cancer
  • Previous surgical biopsy
  • Placement of an internal breast marker
  • Unable to understand and or execute written informed consent

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: Diagnostic
  • Allocation: Non-Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To detect a 20% reduction in the recall rate when comparing the recall rate using the BIRADS 0 scores of the 2-D plus 3-D images to the 2-D images.
Time Frame: 10-12 months
10-12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To detect a 0.05 increase in the area under the ROC curve when comparing 2-D plus 3-D images to the 2-D images.
Time Frame: 10-12 months
10-12 months

Collaborators and Investigators

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

Sponsor

Hologic, Inc.

Investigators

  • Principal Investigator: Elizabeth Rafferty, M.D, Massachusetts General Hospital

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 (Actual)

July 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 10, 2008

First Submitted That Met QC Criteria

September 17, 2008

First Posted (Estimate)

September 18, 2008

Study Record Updates

Last Update Posted (Actual)

August 12, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-01 (German Cancer Society)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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