Comparison of Digital Breast Tomosynthesis to Conventional Mammography

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03442478

Enrollment

100

Registered

2018-02-22

Start date

2012-05-31

Completion date

2016-05-31

Last updated

2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

OTHER2D/3D Tomosynthesis

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026