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

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00754598
• Lead Sponsor: Hologic, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2007-05
• Study Completion: 2007-07
• Status Verified: 2008-09
• Study First Submitted: 2008-09-10
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1183

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	10-12 months

Secondary Outcome Measures

Name	Time	Method
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.	10-12 months

Trial Locations

Locations (5)

University of Iowa Medical Center; 🇺🇸 Iowa City, Iowa, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Magee Women's Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States