Back to resultsA Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses
Primary Purpose
Fibrocystic Disease of Breast, Breast Cancer
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Digital Breast Tomosynthesis
Sponsored by
About this trial
This is an interventional diagnostic trial for Fibrocystic Disease of Breast focused on measuring Breast Cancer, Mammography, Benign masses, Breast Lump, Breast Biopsy, Breast Mass
Eligibility 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
Sites / Locations
- JoAnne Knight Breast Center, Barnes Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
observational
Arm Description
Observational
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00826488
First Posted
January 20, 2009
Last Updated
June 1, 2015
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00826488
Brief Title
A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses
Official Title
A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrocystic Disease of Breast, Breast Cancer
Keywords
Breast Cancer, Mammography, Benign masses, Breast Lump, Breast Biopsy, Breast Mass
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
observational
Arm Type
Other
Arm Description
Observational
Intervention Type
Device
Intervention Name(s)
Digital Breast Tomosynthesis
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dione Farria, MD MPH
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
JoAnne Knight Breast Center, Barnes Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses
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