Breast Lesion Analysis for Tomosynthesis Mammography

Breast Cancer Clinical Trial

Official title:

Tomosynthesis Mammography: Computer-Aided Analysis of Breast Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723541
• Other study ID #: HUM 00003483
• Secondary ID: 5R01CA151443-05
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Est. completion date: July 12, 2016

Study information

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

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 872
• Est. completion date: July 12, 2016
• Est. primary completion date: July 12, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Subjects scheduled for core biopsy of a breast lesion

Exclusion Criteria:

• Pregnant females

Related Conditions & MeSH terms

• Abnormal Findings on Radiological Examination of Breast
• Breast Cancer
• Signs and Symptoms

Intervention

Procedure:
• Computer aided analysis of breast lesions
Tomosynthesis mammography and computer aided analysis of breast lesions to aid in detection of breast cancer.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achieve earlier breast cancer detection and characterization		1 year