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Visibility of Lesion Characteristics With Phase Contrast Mammography
This study has been completed.
Study NCT00467727   Information provided by The University of North Carolina, Chapel Hill
First Received: April 29, 2007   Last Updated: March 2, 2009   History of Changes

April 29, 2007
March 2, 2009
April 2007
March 2008   (final data collection date for primary outcome measure)
Measure: Lesion Visibility Comparison of Phase Contrast Mammography with X-Ray Mammography. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Measure: Lesion Visibility Comparison of Phase Contrast Mammography with X-Ray Mammography. [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00467727 on ClinicalTrials.gov Archive Site
 
 
 
Visibility of Lesion Characteristics With Phase Contrast Mammography
Lesion Characteristics' Visibility With Phase Contrast Mammography in Comparison to X-Ray Mammography for Women Undergoing X-Ray Diagnostic 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).

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

 
Interventional
Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Breast Cancer
Other: Phase Contrast Mammography
Experimental: Phase Contrast Mammography Exam

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
53
September 2008
March 2008   (final data collection date for primary outcome measure)

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
Female
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00467727
Etta D. Pisano, MD / Principal Investigator, University of North Carolina at Chapel Hill
LCCC0702
The University of North Carolina, Chapel Hill
 
Principal Investigator: Etta D Pisano, MD The University of North Carolina at Chapel Hill
The University of North Carolina, Chapel Hill
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP