Comparison of Digital Breast Tomosynthesis to Conventional Mammography

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: 2D/3D Tomosynthesis

• Registration Number: NCT03442478
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Study First Submitted: 2018-02-16
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-22
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-11
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Comparison of Tomosynthesis to Standard Digital Mammography	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.

Trial Locations

Locations (1)

Princess Margaret Cancer Centre, University Health Network, 610 University Ave.; 🇨🇦 Toronto, Ontario, Canada