We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Breast Lesion Analysis for Tomosynthesis Mammography

This study is currently recruiting participants.
Verified January 2017 by Heang-Ping Chan Ph.D, University of Michigan
Sponsor:
ClinicalTrials.gov Identifier:
NCT00723541
First Posted: July 28, 2008
Last Update Posted: January 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Heang-Ping Chan Ph.D, University of Michigan
  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 Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Heang-Ping Chan Ph.D, University of Michigan:

Primary Outcome Measures:
  • Achieve earlier breast cancer detection and characterization [ Time Frame: 1 year ]

Estimated Enrollment: 800
Study Start Date: January 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 24, 2008
First Posted: July 28, 2008
Last Update Posted: January 13, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No


To Top