Digital Mammography: Computer-Aided Breast Cancer Diagnosis

University of Michigan

Status: Completed

Conditions: Tumors, Breast

Treatments: Procedure: digital mammography

Study type: Interventional

Funder types: Other

Identifiers

NCT00732433

2000-0227 HUM 42465

Details and patient eligibility

About

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.

Full 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.

Enrollment: 433 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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433 participants in 1 patient group

digital mammogram

Experimental group

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.

Treatment:

Procedure: digital mammography