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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00467727
Enrollment
53
Registered
2007-05-01
Start date
2007-04-30
Completion date
2008-09-30
Last updated
2012-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Diagnostic Mammography, Breast Imaging, Phase Contrast Mammography, X-Ray Mammography

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).

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

Interventions

OTHERPhase Contrast Mammography

Standard and magnification views

Sponsors

UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Measure: Lesion Visibility Comparison of Phase Contrast Mammography with X-Ray Mammography.12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026