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Breast Lesion Analysis for Tomosynthesis Mammography

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 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 16, 2016
Last verified: June 2016
  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
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:


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: December 2017
Estimated Primary Completion Date: December 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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: 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 16, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

ClinicalTrials.gov processed this record on September 26, 2016