Back to resultsA Comparison of the 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography for Breast Abnormalities
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D mammograpgy system
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast cancer, Tomosynthesis, 3D Mammogram, Diagnostic mammogram
Eligibility Criteria
Inclusion Criteria: Subject is female of any race and ethnicity Subject is at least 40 years old The screening and diagnostic mammograms were performed at the recruiting institution on a Hologic Selenia System Subject is categorized as BI-RADS 0 because if mass, density, or calcifications detected on the basis of screening or diagnostic mammography Subject will undergo study imaging within 30 days of standard of care imaging Exclusion Criteria: Patients who are pregnant or think they may be pregnant Patients who are breast feeding Subjects unable or unwilling to undergo informed consent Subjects with breast implants
Sites / Locations
- University of Iowa
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3D investigational imaging
Arm Description
patients returning with an area of interest will undergo 3D imaging in 2 modes of imaging to the breast of interest
Outcomes
Primary Outcome Measures
If the new imaging modes are successful, they will represent a method of reducing patient exposure for future imaging because they are designed to be used in 3D imaging only.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00990483
Brief Title
A Comparison of the 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography for Breast Abnormalities
Official Title
A Comparison of 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography in the Visualization and Characterization of Breast Abnormalities
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hologic, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to conduct an initial investigation into whether an alternative method of using 3D imaging might offer accurate diagnostic performance at a reduced patient radiation exposure in comparison to conventional 2D screening and diagnostic mammography and conventional 2D + 3D imaging methods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Tomosynthesis, 3D Mammogram, Diagnostic mammogram
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3D investigational imaging
Arm Type
Experimental
Arm Description
patients returning with an area of interest will undergo 3D imaging in 2 modes of imaging to the breast of interest
Intervention Type
Device
Intervention Name(s)
3D mammograpgy system
Other Intervention Name(s)
Selenia Dimensions, Tomosynthesis
Intervention Description
In addition to the standard care diagnostic imaging, all participants underwent two experimental acquisitions, in two projections (Cranio-Caudal and Mediolateral Oblique) on the breast of concern: one acquisition in Mode A (narrow angle acquisition) and one acquisition in Mode B (wide angle acquisition).
Primary Outcome Measure Information:
Title
If the new imaging modes are successful, they will represent a method of reducing patient exposure for future imaging because they are designed to be used in 3D imaging only.
Time Frame
Fall 2010
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is female of any race and ethnicity
Subject is at least 40 years old
The screening and diagnostic mammograms were performed at the recruiting institution on a Hologic Selenia System
Subject is categorized as BI-RADS 0 because if mass, density, or calcifications detected on the basis of screening or diagnostic mammography
Subject will undergo study imaging within 30 days of standard of care imaging
Exclusion Criteria:
Patients who are pregnant or think they may be pregnant
Patients who are breast feeding
Subjects unable or unwilling to undergo informed consent
Subjects with breast implants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie Farjardo, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison of the 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography for Breast Abnormalities
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