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Breast Lesion Analysis for Tomosynthesis Mammography

This study is currently recruiting participants.
Verified June 2012 by University of Michigan
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Heang-Ping Chan Ph.D, University of Michigan
ClinicalTrials.gov Identifier:
NCT00723541
First received: July 24, 2008
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  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
Other (Abnormal) Findings on Radiological Examination of Breast
 Procedure: Computer aided analysis of breast lesions
 Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Tomosynthesis Mammography: Computer-Aided Analysis of Breast Lesions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Achieve earlier breast cancer detection and characterization [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: January 2008
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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: Heang-Ping Chan Ph.D, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00723541     History of Changes
Other Study ID Numbers: HUM 00003483, NIH
Study First Received: July 24, 2008
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013