Breast Lesion Analysis for Tomosynthesis Mammography

This study is currently recruiting participants.

Verified by University of Michigan, February 2009

First Received: July 24, 2008 Last Updated: February 17, 2009 History of Changes

Sponsors and Collaborators:	University of Michigan National Institutes of Health (NIH)
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00723541

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Breast Abnormalities	Procedure: Computer aided analysis of breast lesions	Phase 0

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Tomosynthesis Mammography: Computer-Aided Analysis of Breast Lesions

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mammography

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

To improve breast cancer detection and characterization [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	January 2008

Arms	Assigned Interventions
A: Experimental Develop a computer-aided diagnostic system that will aid in the screening and detection of breast abnormalities/cancer	Procedure: Computer aided analysis of breast lesions Tomosynthesis mammography and computer aided analysis of breast lesions to aid in detection of breast cancer.

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).

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects scheduled for core biopsy of a breast lesion

Exclusion Criteria:

Pregnant females

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723541

Contacts

Contact: Heang-Ping Chan, Ph.D.

734-936-4357

chanhp@umich.edu

Locations

United States, Michigan
University of Michigan Health System	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Heang-Ping Chan, Ph.D. 734-936-4357 chanhp@umich.edu
Principal Investigator: Heang-Ping Chan, Ph.D

Sponsors and Collaborators

University of Michigan

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Heang-Ping Chan, Ph.D.

University of Michigan

More Information

No publications provided

Responsible Party:	University of Michigan ( Heang-Ping Chan, Ph.D. )
Study ID Numbers:	HUM 3483, NIH
Study First Received:	July 24, 2008
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00723541 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Congenital Abnormalities
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases

Breast Neoplasms
Congenital Abnormalities
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009