Status:
COMPLETED
Image Evaluation of Philips Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)
Lead Sponsor:
Philips Healthcare
Conditions:
Breast Cancer
Eligibility:
FEMALE
40+ years
Brief Summary
The purpose of this investigation, using hardcopy film, is to compare the accuracy of the Philips MammoDiagnost DR (FFDM device) and screen-film (SF) mammography in detection of breast cancer among wo...
Detailed Description
The proposed research study is a prospective enriched reader trial in which patients who meet the study's eligibility criteria, subject to certain constraints specified in this protocol, will undergo ...
Eligibility Criteria
Inclusion
- Patient underwent or is scheduled to undergo a screening or diagnostic mammogram examination (right and left craniocaudal and mediolateral oblique with or without special views) at one of the acquisition centers during the course of this research study.
- At least 40 years of age
- Provides written informed consent indicating willingness to participate in this research study prior to performance of the Philips FFDM mammogram
- Meets none of the exclusion criteria
Exclusion
- Presence of a breast implant,
- Patients undergoing a unilateral mammogram or an incomplete SF mammogram
- had previously undergone an excisional breast biopsy
- Pregnant women or patients who believe they may be pregnant
- (f) Inmates (in accordance with 45 CFR 46.306)
- (g) Patients who cannot, for any reason, undergo follow-up mammography examinations (where clinically indicated) at the participating institution
Key Trial Info
Start Date :
April 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00999596
Start Date
April 1 2010
End Date
September 1 2011
Last Update
December 4 2012
Active Locations (3)
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1
University of Alabama
Birmingham, Alabama, United States, 35249
2
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037
3
Strahleninstitut CDT
Cologne, Germany