Expired Study
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Ann Arbor, Michigan 48109


Purpose:

The purpose of this study is to develop computer programs to assist radiologists in finding breast cancer on mammograms and to compare the computer's accuracy of detecting cancers on direct digital and film mammograms.


Study summary:

To develop a computer-aided diagnosis (CAD) system for full field digital mammography (FFDM) using advanced computer vision techniques and to evaluate the effects of CAD on interpretation of digital mammograms (DMs). This system will assist radiologists with the four most important areas in mammographic interpretation: (1) detection of masses, (2) classification of masses, (3) detection of microcalcifications, (4) classification of microcalcifications. The proposed approach is distinctly different from previous approaches in that image information from two-view and bilateral mammograms will be fused with that from the single-view mammogram to improve lesion detection and characterization.


Criteria:

Inclusion Criteria: - Females who have been scheduled for mammographic exams. - Females who have been recommended for work-up or biopsy due to a suspicious finding on their mammogram. - Females who can give informed consent. Exclusion Criteria: - No subject under 18 years of age


Study is Available At:


Original ID:

2000-0227 HUM 42465


NCT ID:

NCT00732433


Secondary ID:


Study Acronym:


Brief Title:

Digital Mammography: Computer-Aided Breast Cancer Diagnosis


Official Title:

Digital Mammography: Computer-Aided Breast Cancer Diagnosis


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Michigan


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

500


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Heang-Ping Chan, Ph.D.
Principal Investigator
University of Michigan

Study Dates

Start Date:June 2000
Completion Date:January 2025
Completion Type:Anticipated
Primary Completion Date:January 2025
Primary Completion Type:Anticipated
Verification Date:September 2019
Last Changed Date:September 12, 2019
First Received Date:August 7, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Using computer aided programs to assist in detection and characterization of breast lesions in digital mammography.
Time Frame:Research scan will be completed at the time of scheduled clinical visit.
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:digital mammography
Description:Using non-invasive digital mammography with computer aided programs to screen, detect and characterize breast lesions/cancer.
Arm Name:digital mammogram

Study Arms

Study Arm Type:Experimental
Arm Name:digital mammogram
Description:Digital mammography is a non-invasive imaging technique to obtain an x-ray image of the breast. Two-view digital mammogram of the breast with a lesion that has been recommended for biopsy during the subject's regular clinical care. The digital mammogram is then analyzed by a computer program.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Michigan

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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