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Breast Lesion Analysis for Tomosynthesis Mammography

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ClinicalTrials.gov Identifier: NCT00723541
Recruitment Status : Recruiting
First Posted : July 28, 2008
Last Update Posted : January 11, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Heang-Ping Chan Ph.D, University of Michigan

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Abnormal Findings on Radiological Examination of Breast Procedure: Computer aided analysis of breast lesions Early Phase 1

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Tomosynthesis Mammography: Computer-Aided Analysis of Breast Lesions
Study Start Date : January 2008
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arm Intervention/treatment
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.




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


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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

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

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 Posted: July 28, 2008    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No