NCT00754598

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,183 (actual)
• Sponsor: Hologic, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-05-01
• Completion: 2007-07-01
• First posted: 2008-09-18
• Last updated: 2022-08-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study