Digital Mammography: Computer-Aided Breast Cancer Diagnosis
Primary Purpose
Tumors, Breast
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
digital mammography
Sponsored by

About this trial
This is an interventional diagnostic trial for Tumors, Breast
Eligibility Criteria
Inclusion Criteria:
- Females who have been scheduled for mammographic exams.
- Females who have been recommended for work-up or biopsy due to a suspicious finding on their mammogram.
- Females who can give informed consent.
Exclusion Criteria:
- No subject under 18 years of age
Sites / Locations
- University of Michigan Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
digital mammogram
Arm Description
Digital mammography is a non-invasive imaging technique to obtain an x-ray image of the breast. Two-view digital mammogram of the breast with a lesion that has been recommended for biopsy during the subject's regular clinical care. The digital mammogram is then analyzed by a computer program.
Outcomes
Primary Outcome Measures
Using computer aided programs to assist in detection and characterization of breast lesions in digital mammography.
Secondary Outcome Measures
Full Information
NCT ID
NCT00732433
First Posted
August 7, 2008
Last Updated
January 27, 2020
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT00732433
Brief Title
Digital Mammography: Computer-Aided Breast Cancer Diagnosis
Official Title
Digital Mammography: Computer-Aided Breast Cancer Diagnosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 2000 (Actual)
Primary Completion Date
April 30, 2008 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to develop computer programs to assist radiologists in finding breast cancer on mammograms and to compare the computer's accuracy of detecting cancers on direct digital and film mammograms.
Detailed Description
To develop a computer-aided diagnosis (CAD) system for full field digital mammography (FFDM) using advanced computer vision techniques and to evaluate the effects of CAD on interpretation of digital mammograms (DMs). This system will assist radiologists with the four most important areas in mammographic interpretation: (1) detection of masses, (2) classification of masses, (3) detection of microcalcifications, (4) classification of microcalcifications. The proposed approach is distinctly different from previous approaches in that image information from two-view and bilateral mammograms will be fused with that from the single-view mammogram to improve lesion detection and characterization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumors, Breast
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
433 (Actual)
8. Arms, Groups, and Interventions
Arm Title
digital mammogram
Arm Type
Experimental
Arm Description
Digital mammography is a non-invasive imaging technique to obtain an x-ray image of the breast.
Two-view digital mammogram of the breast with a lesion that has been recommended for biopsy during the subject's regular clinical care. The digital mammogram is then analyzed by a computer program.
Intervention Type
Procedure
Intervention Name(s)
digital mammography
Intervention Description
Using non-invasive digital mammography with computer aided programs to screen, detect and characterize breast lesions/cancer.
Primary Outcome Measure Information:
Title
Using computer aided programs to assist in detection and characterization of breast lesions in digital mammography.
Time Frame
Research scan will be completed at the time of scheduled clinical visit.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Females who have been scheduled for mammographic exams.
Females who have been recommended for work-up or biopsy due to a suspicious finding on their mammogram.
Females who can give informed consent.
Exclusion Criteria:
No subject under 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heang-Ping Chan, Ph.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
Digital Mammography: Computer-Aided Breast Cancer Diagnosis
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