Comparison of Digital Breast Tomosynthesis to Conventional Mammography

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University Health Network, Toronto

Status

Completed

Conditions

Breast Cancer

Treatments

Other: 2D/3D Tomosynthesis

Study type

Interventional

Funder types

Other

Identifiers

NCT03442478
12-0138-C

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

Female

Ages

40+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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