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Breast Lesion Analysis for Tomosynthesis Mammography

This study is currently recruiting participants.
Verified by University of Michigan, August 2008

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

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Mammography   

U.S. FDA Resources

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

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


Responsible Party:   University of Michigan ( Heang-Ping Chan, Ph.D. )
Study ID Numbers:   HUM 3483, NIH
First Received:   July 24, 2008
Last Updated:   August 20, 2008
ClinicalTrials.gov Identifier:   NCT00723541
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

ClinicalTrials.gov processed this record on October 24, 2008




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