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Sponsored by: |
The University of North Carolina, Chapel Hill |
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Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00467727 |
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).
Condition | Intervention |
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Breast Cancer |
Other: Phase Contrast Mammography |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Lesion Characteristics' Visibility With Phase Contrast Mammography in Comparison to X-Ray Mammography for Women Undergoing X-Ray Diagnostic Mammography |
Enrollment: | 53 |
Study Start Date: | April 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Phase Contrast Mammography Exam
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Other: Phase Contrast Mammography
Standard and magnification views
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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
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Carolina Center for Clinical Trials, University of North Carolina | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | Etta D Pisano, MD | The University of North Carolina at Chapel Hill |
Responsible Party: | University of North Carolina at Chapel Hill ( Etta D. Pisano, MD / Principal Investigator ) |
Study ID Numbers: | LCCC0702 |
Study First Received: | April 29, 2007 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00467727 |
Health Authority: | United States: Institutional Review Board |
Diagnostic Mammography Breast Imaging Phase Contrast Mammography X-Ray Mammography |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |