Visibility of Lesion Characteristics With Phase Contrast Mammography - Full Text View

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

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer Mammography X-Rays

ChemIDplus related topics:

X-Rays

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	Lesion Characteristics' Visibility With Phase Contrast Mammography in Comparison to X-Ray Mammography for Women Undergoing X-Ray Diagnostic Mammography

Further study details as provided by University of North Carolina:

Primary Outcome Measures:

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

Estimated Enrollment:	75
Study Start Date:	April 2007
Estimated Study Completion Date:	May 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

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

Contacts


Contact: Elodia Cole	919-843-6936	ecole@unc.edu

Locations


United States, North Carolina
	Carolina Center for Clinical Trials, University of North Carolina	Recruiting
	Chapel Hill, North Carolina, United States, 27599
	Contact: Doreen Steed 919-966-2866 doreen_steed@med.unc.edu
	Principal Investigator: Etta D Pisano, MD

Sponsors and Collaborators

University of North Carolina

Investigators


Principal Investigator:	Etta D Pisano, MD	The University of North Carolina at Chapel Hill

More Information

UNC Breast Imaging Research Lab Research Projects This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

Responsible Party:	University of North Carolina at Chapel Hill ( Etta D. Pisano, MD / Principal Investigator )
Study ID Numbers:	LCCC0702
First Received:	April 29, 2007
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00467727
Health Authority:	United States: Institutional Review Board

Keywords provided by University of North Carolina:

Diagnostic Mammography

Breast Imaging

Phase Contrast Mammography

X-Ray Mammography

Study placed in the following topic categories:

Skin Diseases

Breast Neoplasms

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	University of North Carolina
Information provided by:	University of North Carolina
ClinicalTrials.gov Identifier:	NCT00467727