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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00826488
First received: January 20, 2009
Last updated: February 8, 2010
Last verified: February 2010
  Purpose

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: Allocation: Non-Randomized
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 ]

Estimated Enrollment: 136
Study Start Date: March 2009
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826488

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

No publications provided

Responsible Party: Dione Farria, MD MPH, 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: February 8, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 29, 2014