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
1 other identifier
interventional
53
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Apr 2007
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 29, 2007
CompletedFirst Posted
Study publicly available on registry
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedMay 1, 2012
April 1, 2012
11 months
April 29, 2007
April 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure: Lesion Visibility Comparison of Phase Contrast Mammography with X-Ray Mammography.
12 months
Study Arms (1)
1
EXPERIMENTALPhase Contrast Mammography Exam
Interventions
Eligibility Criteria
You may qualify if:
- At least 40 years old
- Female
- Scheduled for diagnostic work-up including compression/magnification views of screening detected breast lesion
You may not qualify if:
- \< 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carolina Center for Clinical Trials, University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Related Publications (3)
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.
PMID: 12727392BACKGROUNDTanaka 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.
PMID: 15973129BACKGROUNDPisano 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.
PMID: 10966717BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Etta D Pisano, MD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2007
First Posted
May 1, 2007
Study Start
April 1, 2007
Primary Completion
March 1, 2008
Study Completion
September 1, 2008
Last Updated
May 1, 2012
Record last verified: 2012-04