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| Tracking Information | |||||
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| First Received Date ICMJE | April 29, 2007 | ||||
| Last Updated Date | March 2, 2009 | ||||
| Start Date ICMJE | April 2007 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Measure: Lesion Visibility Comparison of Phase Contrast Mammography with X-Ray Mammography. [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Measure: Lesion Visibility Comparison of Phase Contrast Mammography with X-Ray Mammography. [ Time Frame: 6 months ] | ||||
| Change History | Complete list of historical versions of study NCT00467727 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Visibility of Lesion Characteristics With Phase Contrast Mammography | ||||
| Official Title ICMJE | Lesion Characteristics' Visibility With Phase Contrast Mammography in Comparison to X-Ray Mammography for Women Undergoing X-Ray Diagnostic Mammography | ||||
| Brief Summary | To determine if diagnostic phase contrast mammography (PCM) will provide improved image detail in assessing lesion characteristics when compared to diagnostic x-ray mammography (XM). |
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| Detailed Description | The ability to detect lesions in mammography before they can be felt is the benefit of using this imaging modality for screening of breast cancer. Screening mammography has been proven to decrease mortality from breast cancer. Radiologists identify abnormal breast tissue in the form of microcalcifications, masses, architectural distortion, and asymmetric density by careful assessment of the characteristics of these types of lesions using the Breast Imaging Reporting and Diagnostic System (BIRADS). BIRADS was developed to provide standardization of reporting of mammographic exams. In screening mammography, while it is possible to detect lesions, often more detailed diagnostic imaging is necessary to improve the visibility of margins and edges of lesions through magnification and compression views of the lesion of interest due to spatial resolution limitations which causes geometric blurring of edges in x-ray mammography. If the ability to clearly see margins and edges of lesions is possible at screening mammography, this would potentially decrease the overall radiation exposure currently needed to allow radiologists to be confident of their characterizations for the majority of patients using x-ray mammography. Digital mammography was developed to improve the visibility of lesions primarily in dense breasts. The reasoning was that the improved contrast range would allow for wider range of gray level differentiation but with digital mammography comes a spatial resolution limitation that blurred edges of lesions. Phase contrast mammography (PCM) was developed to improve digital mammography by providing improvement in sharpness of edges utilizing the x-ray properties of refraction. Comparison: Phase Contrast Mammography to X-Ray Mammography for Lesion Visibility of Diagnostic Population |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE | Other: Phase Contrast Mammography | ||||
| Study Arms / Comparison Groups | Experimental: Phase Contrast Mammography Exam | ||||
| 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 ICMJE | Completed | ||||
| Enrollment ICMJE | 53 | ||||
| Completion Date | September 2008 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 40 Years and older | ||||
| 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 ID ICMJE | NCT00467727 | ||||
| Responsible Party | Etta D. Pisano, MD / Principal Investigator, University of North Carolina at Chapel Hill | ||||
| Study ID Numbers ICMJE | LCCC0702 | ||||
| Study Sponsor ICMJE | The University of North Carolina, Chapel Hill | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | The University of North Carolina, Chapel Hill | ||||
| Verification Date | March 2009 | ||||
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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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