Digital Mammography: Computer-Aided Breast Cancer Diagnosis
January 27, 2020 updated by: Heang-Ping Chan Ph.D, University of Michigan
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
433
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Health System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: digital mammogram
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. |
Using non-invasive digital mammography with computer aided programs to screen, detect and characterize breast lesions/cancer.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
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Research scan will be completed at the time of scheduled clinical visit.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Heang-Ping Chan, Ph.D., University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2000
Primary Completion (Actual)
April 30, 2008
Study Completion (Actual)
January 1, 2020
Study Registration Dates
First Submitted
August 7, 2008
First Submitted That Met QC Criteria
August 7, 2008
First Posted (Estimate)
August 12, 2008
Study Record Updates
Last Update Posted (Actual)
January 29, 2020
Last Update Submitted That Met QC Criteria
January 27, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000-0227 HUM 42465
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.