Digital Mammography: Computer-Aided Breast Cancer Diagnosis
| Tracking Information | |||||
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| First Received Date ICMJE | August 7, 2008 | ||||
| Last Updated Date | June 12, 2012 | ||||
| Start Date ICMJE | June 2000 | ||||
| Estimated Primary Completion Date | August 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Using computer aided programs to assist in detection and characterization of breast lesions in digital mammography. [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00732433 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Digital Mammography: Computer-Aided Breast Cancer Diagnosis | ||||
| Official Title ICMJE | Digital Mammography: Computer-Aided Breast Cancer Diagnosis | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: digital mammography
Using non-invasive digital mammography with computer aided programs to screen, detect and characterize breast lesions/cancer. |
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| Study Arm (s) | Experimental: A.
Intervention: Procedure: digital mammography |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 500 | ||||
| Estimated Completion Date | August 2015 | ||||
| Estimated Primary Completion Date | August 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00732433 | ||||
| Other Study ID Numbers ICMJE | 2000-0227, NIH (CA 95153) | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Heang-Ping Chan Ph.D, University of Michigan | ||||
| Study Sponsor ICMJE | University of Michigan | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Michigan | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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