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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

DIAGNOSTIC

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Genesis Hologic Tomosynthesis Tomo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No