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

NCT00754598 | Completed FDA Device

• 1 other identifier: 05-01
• Study Type: interventional
• Target: 1,183
• Locations: 1 country
• Sites: 5

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

Conditions

Breast Cancer

Keywords

Breast Cancer; digital mammography; tomosynthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

Tomosynthesis digital mammography imaging system DEVICE

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.

Also known as: Genesis, Hologic Tomosynthesis, Tomo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hologic, Inc.: lead

Study Sites (5)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

University of Iowa Medical Center

Iowa City, Iowa, 52242, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02116, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elizabeth Rafferty, M.D

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Purpose: DIAGNOSTIC
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2008
• First Posted: September 18, 2008
• Study Start: July 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: July 1, 2007
• Last Updated: August 12, 2022

Record last verified: 2008-09

Locations

US (5)