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OpenTrials
Completed

NCT Number: NCT03442478

Comparison of Digital Breast Tomosynthesis to Conventional Mammography

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre, University Health Network, 610 University Ave.

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2D/3D Tomosynthesis

Other

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 22, 2018
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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