Visibility of Lesion Characteristics With Phase Contrast Mammography

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Phase Contrast Mammography

• Registration Number: NCT00467727
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-29
• Study First Submitted QC: 2007-04-30
• Study First Posted: 2007-05-01
• Primary Completion: 2008-03
• Study Completion: 2008-09
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-27
• Last Update Posted: 2012-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Phase Contrast Mammography	Phase Contrast Mammography Exam

Primary Outcome Measures

Name	Time	Method
Measure: Lesion Visibility Comparison of Phase Contrast Mammography with X-Ray Mammography.	12 months

Trial Locations

Locations (1)

Carolina Center for Clinical Trials, University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States