Trial Information
A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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.
Outcome Time Frame:
9 months
Safety Issue:
No
Principal Investigator
Dione Farria, MD MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
Washington University School of Medicine
Authority:
United States: Institutional Review Board
Study ID:
DBT11212008
NCT ID:
NCT00826488
Start Date:
March 2009
Completion Date:
Related Keywords:
- Fibrocystic Disease of Breast
- Breast Cancer
- Breast Cancer
- Mammography
- Benign masses
- Breast Lump
- Breast Biopsy
- Breast Mass
- Breast Neoplasms
- Breast Diseases
- Cystic Fibrosis
- Fibrocystic Breast Disease
Name | Location |
JoAnne Knight Breast Center, Barnes Hospital |
St. Louis, Missouri 63110 |