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

January 20, 2009
February 8, 2010
March 2009
March 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00826488 on ClinicalTrials.gov Archive Site
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A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses
A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study

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.

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Interventional
Phase 0
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Fibrocystic Disease of Breast
  • Breast Cancer
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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
136
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March 2011   (final data collection date for primary outcome measure)

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
Female
35 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00826488
DBT11212008
Yes
Dione Farria, MD MPH, Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Dione Farria, MD MPH Washington University School of Medicine
Washington University School of Medicine
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP