Visibility of Lesion Characteristics With Phase Contrast Mammography
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).
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Lesion Characteristics' Visibility With Phase Contrast Mammography in Comparison to X-Ray Mammography for Women Undergoing X-Ray Diagnostic Mammography|
- Measure: Lesion Visibility Comparison of Phase Contrast Mammography with X-Ray Mammography. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||September 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Phase Contrast Mammography Exam
Other: Phase Contrast Mammography
Standard and magnification views
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467727
|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||University of North Carolina, Chapel Hill|