Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions
This study is currently recruiting participants.
Verified December 2012 by University of Michigan
Sponsor:
University of Michigan
Collaborator:
Information provided by (Responsible Party):
Paul L. Carson Ph.D, University of Michigan
ClinicalTrials.gov Identifier:
NCT00721435
First received: July 22, 2008
Last updated: December 1, 2012
Last verified: December 2012
| Tracking Information | |||||
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| First Received Date ICMJE | July 22, 2008 | ||||
| Last Updated Date | December 1, 2012 | ||||
| Start Date ICMJE | April 2002 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To have a device that produces 3D/ultrasound imaging of the breast at the same time and in the same position. [ Time Frame: To be determned later. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00721435 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 | Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions | ||||
| Official Title ICMJE | Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions | ||||
| Brief Summary | The study will evaluate and refine a breast screening and diagnosis device. |
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| Detailed Description | The device produces 3-D mammograms and ultrasound pictures of the breast at the same time and in the same position. This should help make sure that any area on a mammogram can be easily found in the ultrasound when using the new device. The 3-D mammograms should provide better visualization of the suspected lesion and improve diagnostic accuracy. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Tomosynthesis and ultrasound imaging
3D and ultrasound imaging for breast abnormalities and masses |
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| Study Arm (s) | Experimental: A
Evaluating a non-invasive breast screening and diagnostic device, 3D tomosynthesis and 3D ultrasound. Evaluate the utility of adding ultrasound.
Intervention: Procedure: Tomosynthesis and ultrasound imaging |
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 260 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 25 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00721435 | ||||
| Other Study ID Numbers ICMJE | HUM00045519 (2002-0584) | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Paul L. Carson Ph.D, University of Michigan | ||||
| Study Sponsor ICMJE | University of Michigan | ||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Michigan | ||||
| Verification Date | December 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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