Clinical trial NCT00467727: Visibility of Lesion Characteristics With Phase Contrast Mammography
Official title: Lesion Characteristics' Visibility With Phase Contrast Mammography in Comparison to X-Ray Mammography for Women Undergoing X-Ray Diagnostic Mammography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Diagnostic Mammography
Breast Imaging
Phase Contrast Mammography
X-Ray Mammography
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2007-05-01
Enrollment: 53
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility 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

Primary outcomes:
measure: Measure: Lesion Visibility Comparison of Phase Contrast Mammography with X-Ray Mammography.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Carolina Center for Clinical Trials, University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Etta D Pisano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tabar L, Yen MF, Vitak B, Chen HH, Smith RA, Duffy SW. Mammography service screening and mortality in breast cancer patients: 20-year follow-up before and after introduction of screening. Lancet. 2003 Apr 26;361(9367):1405-10. doi: 10.1016/S0140-6736(03)13143-1.
citation: Tanaka T, Honda C, Matsuo S, Noma K, Oohara H, Nitta N, Ota S, Tsuchiya K, Sakashita Y, Yamada A, Yamasaki M, Furukawa A, Takahashi M, Murata K. The first trial of phase contrast imaging for digital full-field mammography using a practical molybdenum x-ray tube. Invest Radiol. 2005 Jul;40(7):385-96. doi: 10.1097/01.rli.0000165575.43381.48.
citation: Pisano ED, Cole EB, Major S, Zong S, Hemminger BM, Muller KE, Johnston RE, Walsh R, Conant E, Fajardo LL, Feig SA, Nishikawa RM, Yaffe MJ, Williams MB, Aylward SR. Radiologists' preferences for digital mammographic display. The International Digital Mammography Development Group. Radiology. 2000 Sep;216(3):820-30. doi: 10.1148/radiology.216.3.r00se48820.