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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754598
• Other study ID #: 05-01
• Status: Completed
• Phase: N/A
• Start date: July 2006
• Est. completion date: July 2007

Study information

• Verified date: September 2008
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1183
• Est. completion date: July 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Tomosynthesis digital mammography imaging system
a full-field digital mammography system where multiple images are acquired at various angles near the normal to the detector. Breast compression is performed in a standard geometry. The acquired images are reconstructed using mathematical algorithms, not unlike CT reconstructions, to generate a set of thin slices parallel to the breast platform. The reconstructed slices can be viewed individually or in a movie format.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Iowa Medical Center	Iowa City	Iowa
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Magee Women's Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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