Visibility of Lesion Characteristics With Phase Contrast Mammography

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00467727
First received: April 29, 2007
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

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 Intervention
Breast Cancer
Other: Phase Contrast Mammography

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Measure: Lesion Visibility Comparison of Phase Contrast Mammography with X-Ray Mammography. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: April 2007
Study Completion Date: September 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Phase Contrast Mammography Exam
Other: Phase Contrast Mammography
Standard and magnification views

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00467727

Locations
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
Investigators
Principal Investigator: Etta D Pisano, MD University of North Carolina, Chapel Hill
  More Information

Additional Information:
Publications:
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00467727     History of Changes
Other Study ID Numbers: LCCC0702
Study First Received: April 29, 2007
Last Updated: April 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Diagnostic Mammography
Breast Imaging
Phase Contrast Mammography
X-Ray Mammography

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014