Comparison of Digital Breast Tomosynthesis to Conventional Mammography

NCT03442478 | Completed

• 1 other identifier: 12-0138-C
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Comparison of Tomosynthesis to Standard Digital Mammography

  To compare the sensitivity, specificity, positive and negative predictive values of tomosynthesis to conventional digital mammography in visualization and characterization of suspicious abnormalities.

  2 years

Study Arms (1)

2D/3D Tomosynthesis

EXPERIMENTAL

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

Other: 2D/3D Tomosynthesis

Interventions

2D/3D Tomosynthesis OTHER

2D/3D Tomosynthesis

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

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

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Anabel Scaranelo

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 22, 2018
• Study Start: May 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

CA (1)