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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00732433
Other study ID # 2000-0227 HUM 42465
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2000
Est. completion date January 2020

Study information

Verified date January 2020
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 433
Est. completion date January 2020
Est. primary completion date April 30, 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
digital mammography
Using non-invasive digital mammography with computer aided programs to screen, detect and characterize breast lesions/cancer.

Locations

Country Name City State
United States University of Michigan Health System Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Using computer aided programs to assist in detection and characterization of breast lesions in digital mammography. Research scan will be completed at the time of scheduled clinical visit.
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