The Performance of Digital Breast Tomosynthesis Compared to Conventional Mammography in Visualization and Characterization of Suspicious Breast Abnormalities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Comparison of Tomosynthesis to Standard Digital Mammography
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
2D/3D Tomosynthesis
2D/3D Tomosynthesis images will be obtained in addition to standard mammographic images.
Intervention: 2D/3D Tomosynthesis (Other)
Outcomes
Primary Outcomes
Comparison of Tomosynthesis to Standard Digital Mammography
Time Frame: 2 years
To compare the sensitivity, specificity, positive and negative predictive values of tomosynthesis to conventional digital mammography in visualization and characterization of suspicious abnormalities.
Secondary Outcomes
No secondary outcomes reported