Comparison of Digital Breast Tomosynthesis to Conventional Mammography

Breast Cancer Clinical Trial

Official title:

The Performance of Digital Breast Tomosynthesis Compared to Conventional Mammography in Visualization and Characterization of Suspicious Breast Abnormalities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442478
• Other study ID #: 12-0138-C
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: May 2016

Study information

• Verified date: April 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• 2D/3D Tomosynthesis

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre, University Health Network, 610 University Ave.	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Tomosynthesis to Standard Digital Mammography	To compare the sensitivity, specificity, positive and negative predictive values of tomosynthesis to conventional digital mammography in visualization and characterization of suspicious abnormalities.	2 years