Status:
COMPLETED
Comparison of Digital Breast Tomosynthesis to Conventional Mammography
Lead Sponsor:
University Health Network, Toronto
Conditions:
Breast Cancer
Eligibility:
FEMALE
40+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03442478
Start Date
May 1 2012
End Date
May 1 2016
Last Update
April 13 2021
Active Locations (1)
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1
Princess Margaret Cancer Centre, University Health Network, 610 University Ave.
Toronto, Ontario, Canada, M5G 2M9