Digital Mammography: Computer-Aided Breast Cancer Diagnosis

Not Applicable

Completed

• Conditions: Tumors, Breast
• Interventions: Procedure: digital mammography

• Registration Number: NCT00732433
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2000-06
• Primary Completion: 2008-04-30
• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-12
• Status Verified: 2020-01
• Study Completion: 2020-01
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 433

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
digital mammogram	digital mammography	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States