Visibility of Lesion Characteristics With Phase Contrast Mammography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00467727
Recruitment Status : Completed
First Posted : May 1, 2007
Last Update Posted : May 1, 2012
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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).

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Phase Contrast Mammography Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography X-Rays
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Phase Contrast Mammography Exam
Other: Phase Contrast Mammography
Standard and magnification views

Primary Outcome Measures :
  1. Measure: Lesion Visibility Comparison of Phase Contrast Mammography with X-Ray Mammography. [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00467727

United States, North Carolina
Carolina Center for Clinical Trials, University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Principal Investigator: Etta D Pisano, MD University of North Carolina, Chapel Hill