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

40 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Measure: Lesion Visibility Comparison of Phase Contrast Mammography with X-Ray Mammography.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Etta D Pisano, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill


United States: Institutional Review Board

Study ID:




Start Date:

April 2007

Completion Date:

September 2008

Related Keywords:

  • Breast Cancer
  • Diagnostic Mammography
  • Breast Imaging
  • Phase Contrast Mammography
  • X-Ray Mammography
  • Breast Neoplasms



Carolina Center for Clinical Trials, University of North CarolinaChapel Hill, North Carolina  27599