Visibility of Lesion Characteristics With Phase Contrast Mammography

Study Overview
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Brief Summary
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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).

Detailed Description
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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

Official Title
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Lesion Characteristics' Visibility With Phase Contrast Mammography in Comparison to X-Ray Mammography for Women Undergoing X-Ray Diagnostic Mammography

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Phase Contrast Mammography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 40 years old Female Scheduled for diagnostic work-up including compression/magnification views of screening detected breast lesion Exclusion Criteria: < age 40 Male No screening detected findings Breast implants Any women who is pregnant or has reason to believe she is pregnant or lactating Women with breasts larger than the 24 x 30 cm receptor

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Phase Contrast Mammography Exam | Other: Phase Contrast Mammography<br>* Standard and magnification views<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Lesion Visibility Comparison of Phase Contrast Mammography with X-Ray Mammography. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic Mammography, Breast Imaging, Phase Contrast Mammography, X-Ray Mammography