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Comparison of Digital Breast Tomosynthesis to Conventional Mammography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03442478
Recruitment Status : Active, not recruiting
First Posted : February 22, 2018
Last Update Posted : May 6, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: 2D/3D Tomosynthesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Performance of Digital Breast Tomosynthesis Compared to Conventional Mammography in Visualization and Characterization of Suspicious Breast Abnormalities
Actual Study Start Date : May 2012
Actual Primary Completion Date : May 2018
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arm Intervention/treatment
Experimental: 2D/3D Tomosynthesis
2D/3D Tomosynthesis images will be obtained in addition to standard mammographic images.
Other: 2D/3D Tomosynthesis

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03442478

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Canada, Ontario
Princess Margaret Cancer Centre, University Health Network, 610 University Ave.
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Anabel Scaranelo University Health Network, Toronto

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Responsible Party: University Health Network, Toronto Identifier: NCT03442478     History of Changes
Other Study ID Numbers: 12-0138-C
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019