Breast Lesion Analysis for Tomosynthesis Mammography

Not Applicable

Completed

• Conditions: Breast Cancer; Abnormal Findings on Radiological Examination of Breast
• Interventions: Procedure: Computer aided analysis of breast lesions

• Registration Number: NCT00723541
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed 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).

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-07-24
• Study First Submitted QC: 2008-07-24
• Study First Posted: 2008-07-28
• Primary Completion: 2016-07-12
• Study Completion: 2016-07-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-16
• Last Update Posted: 2020-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 872

Inclusion Criteria

• Subjects scheduled for core biopsy of a breast lesion

Exclusion Criteria

• Pregnant females

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Computer aided analysis of breast lesions	Develop a computer-aided diagnostic system that will aid in the screening and detection of breast abnormalities/cancer

Primary Outcome Measures

Name	Time	Method
Achieve earlier breast cancer detection and characterization	1 year

Trial Locations

Locations (1)

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