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| Tracking Information | |||||||||
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| First Received Date † | January 20, 2009 | ||||||||
| Last Updated Date | January 21, 2009 | ||||||||
| Start Date † | January 2009 | ||||||||
| Current Primary Outcome Measures † |
It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup. [ Time Frame: 9 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00826488 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses | ||||||||
| Official Title † | A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study | ||||||||
| Brief Summary | The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. It is thought that non-calcified breast masses will be better visualized with the new 3D technology. |
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| Detailed Description | |||||||||
| Study Phase | Phase 0 | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study | ||||||||
| Condition † |
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| Intervention † | Device: Digital Breast Tomosynthesis | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Not yet recruiting | ||||||||
| Estimated Enrollment † | 125 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 35 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00826488 | ||||||||
| Responsible Party | Dione Farria, MD MPH, Washington University School of Medicine | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Washington University School of Medicine | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Washington University School of Medicine | ||||||||
| Verification Date | January 2009 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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