Comparison of Digital Breast Tomosynthesis to Conventional Mammography

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT03442478

Collaborator

(none)

100

Enrollment

Location

Arm

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

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 1, 2012

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 2D/3D Tomosynthesis

2D/3D Tomosynthesis images will be obtained in addition to standard mammographic images.

Other: 2D/3D Tomosynthesis

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Cancer Centre, University Health Network, 610 University Ave.	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator: Anabel Scaranelo, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT03442478

Other Study ID Numbers:

12-0138-C

First Posted:

Feb 22, 2018

Last Update Posted:

Apr 13, 2021

Last Verified:

Apr 1, 2021

Study Results

No Results Posted as of Apr 13, 2021