A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses

This study has been completed.
Information provided by (Responsible Party):
Darlene Bird, R.T. (M), Washington University School of Medicine
ClinicalTrials.gov Identifier:
First received: January 20, 2009
Last updated: June 1, 2015
Last verified: June 2015
The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. It is thought that non-calcified breast masses will be better visualized with the new 3D technology.

Condition Intervention Phase
Fibrocystic Disease of Breast
Breast Cancer
Device: Digital Breast Tomosynthesis
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study

Resource links provided by NLM:

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup. [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment: 136
Study Start Date: March 2009
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Device: Digital Breast Tomosynthesis
Women with a positive screening mammogram called back for additional views will be asked to undergo an additional Digital Breast Tomosynthesis (3D mammogram) on the affected breast. Radiation dose is somewhat less than that of a screening mammogram.


Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female
  • Any race or ethnicity
  • At least 35 years old
  • Prior screening or full diagnostic mammogram at Barnes Jewish Breast Health Center

Exclusion Criteria:

  • Unable or unwilling to undergo informed consent
  • Subjects who have breast implants
  • Subjects who are unable or unwilling to tolerate compression
  • Subjects who are pregnant or who think they may be pregnant
  • Subjects who are currently lactating
  • Men
  • Women less than 35 years old
  • Women greater than 80 years old
  • Subjects whose breasts are larger than the tomosynthesis detector
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00826488

United States, Missouri
JoAnne Knight Breast Center, Barnes Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Dione Farria, MD MPH Washington University School of Medicine
  More Information

Responsible Party: Darlene Bird, R.T. (M), Research Coordinator, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00826488     History of Changes
Other Study ID Numbers: DBT11212008 
Study First Received: January 20, 2009
Last Updated: June 1, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Breast Cancer
Benign masses
Breast Lump
Breast Biopsy
Breast Mass

Additional relevant MeSH terms:
Breast Diseases
Cystic Fibrosis
Fibrocystic Breast Disease
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Respiratory Tract Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 25, 2016