Back to resultsDetection and/or Evaluation of Dense Breast Abnormalities Using Tomosynthesis and Digital Mammography
Primary Purpose
Breast Neoplasms, Breast Abnormalities
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Breast Tomosynthesis
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Females 30 years of age or older.
- Dense Breasts.
- Has undergone clinical two view mammogram and diagnostic breast imaging evaluation.
- Suspicious or palpable mass and scheduled for biopsy.
Exclusion Criteria:
- Pregnant or lactating women.
- Prior personal history of breast cancer.
- Prior breast augmentation with implants or silicon injection. male patients.
- No two view mammogram as part of breast imaging evaluation.
- Breast density of almost entirely fatty/scattered fibroglandular densities.
Sites / Locations
- University of Michigan Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Subjects will undergo a 3D breast Tomosynthesis imaging scan. This is a one time breast imaging scan will last approximately 15 minutes.
Outcomes
Primary Outcome Measures
Measure of digital tomosynthesis and digital mammography test performance.
Interest of sensitivity, specificity and area under region of concern curve for malignant mass detection. During review, the number of masses and location and size of each mass will be recorded. An additional estimate of probability of malignancy will be recorded for each image sets.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00722059
Brief Title
Detection and/or Evaluation of Dense Breast Abnormalities Using Tomosynthesis and Digital Mammography
Official Title
Assessment of Emerging Technology: Comparison of Breast Tomosynthesis and Digital Mammography in the Evaluation of Heterogeneously Dense and Extremely Dense Breasts
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Breast Abnormalities
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Subjects will undergo a 3D breast Tomosynthesis imaging scan. This is a one time breast imaging scan will last approximately 15 minutes.
Intervention Type
Procedure
Intervention Name(s)
Breast Tomosynthesis
Intervention Description
3D breast imaging
Primary Outcome Measure Information:
Title
Measure of digital tomosynthesis and digital mammography test performance.
Description
Interest of sensitivity, specificity and area under region of concern curve for malignant mass detection. During review, the number of masses and location and size of each mass will be recorded. An additional estimate of probability of malignancy will be recorded for each image sets.
Time Frame
3 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Females 30 years of age or older.
Dense Breasts.
Has undergone clinical two view mammogram and diagnostic breast imaging evaluation.
Suspicious or palpable mass and scheduled for biopsy.
Exclusion Criteria:
Pregnant or lactating women.
Prior personal history of breast cancer.
Prior breast augmentation with implants or silicon injection. male patients.
No two view mammogram as part of breast imaging evaluation.
Breast density of almost entirely fatty/scattered fibroglandular densities.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis V. Nees, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Detection and/or Evaluation of Dense Breast Abnormalities Using Tomosynthesis and Digital Mammography
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