Breast Lesion Analysis for Tomosynthesis Mammography

University of Michigan

Status: Completed

Conditions: Abnormal Findings on Radiological Examination of Breast; Breast Cancer

Treatments: Procedure: Computer aided analysis of breast lesions

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00723541

5R01CA151443-05 (U.S. NIH Grant/Contract)

HUM 00003483

Details and patient eligibility

About

The purpose of this study is to develop a computer-aided diagnosis system to find breast lesions, including masses and microcalcifications, which hopefully will improve breast cancer detection and classification.

Full description

The purpose of this study is to develop a computer-aided diagnosis system to find breast lesions, including masses and microcalcifications, and determine if the lesion is a cancer or not for digital tomosynthesis mammography (DTM).

Enrollment: 872 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects scheduled for core biopsy of a breast lesion

Exclusion criteria

• Pregnant females

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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872 participants in 1 patient group

A

Experimental group

Description:

Develop a computer-aided diagnostic system that will aid in the screening and detection of breast abnormalities/cancer

Treatment:

Procedure: Computer aided analysis of breast lesions