Image Evaluation of Philips Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)
Completed
Conditions studied: Breast Cancer
In brief
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 women undergoing screening or diagnostic mammography. Per the new FDA Guidance document for FFDM, accuracy in comparison to Screen-film is no longer required.
Key facts
- Study ID
- NCT00999596
- Run by
- Philips Healthcare
- People needed
- 107
- Starts
- 2010-04-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2012-12-04
Who can join
Age: 40 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama — Birmingham, Alabama, United States
- George Washington Medical Faculty Associates — Washington D.C., District of Columbia, United States
- Strahleninstitut CDT — Cologne, Germany
Full record on ClinicalTrials.gov
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