Comparison of Digital Breast Tomosynthesis to Conventional 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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-05-31

Brief Summary

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In March 2009, Health Canada approved Tomosynthesis for use in screening and diagnosis of breast cancer. The Tomosynthesis technology is designed as a complementary imaging model that is incorporated into the 2D Mammography system. This new imaging system has the capability to provide 2D, 3D and combination mode models. It consists of generating thin slice images that can be viewed individually as multiple images from the same breast. Tomosynthesis provides improved visibility of possible lesions within the breast. The study aims to compare the performance of Tomosynthesis to the conventional Digital Mammography in detecting and characterizing suspicious findings in subjects who will be having breast biopsies.

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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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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2D/3D Tomosynthesis

2D/3D Tomosynthesis images will be obtained in addition to standard mammographic images.

Group Type EXPERIMENTAL

2D/3D Tomosynthesis

Intervention Type OTHER

Interventions

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2D/3D Tomosynthesis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject is female of any race and ethnicity
* Following routine mammography imaging, subject is categorized as Breast Imaging Reporting and Data System (BI-RADS®) 4 or 5 because of calcifications / masses and architectural distortion will undergo study imaging within 30 days of routine imaging
* Subject will undergo 2D/3D digital breast tomosynthesis prior to biopsy

Exclusion Criteria

* Subject unable or unwilling to undergo informed consent
* Subjects who are unable or unwilling to tolerate compression
* Subjects who are pregnant or who think they may be pregnant
* Subjects who are breast-feeding
* The subject is too large to be imaged on the large 24 x 30 cm detector

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No