At a glance
ClinicalIndex Comparison RecordN/ACompleted· 107 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Image Evaluation Study for Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)
In Brief
An observational study for Breast Cancer. Completed, enrolled 107 participants across 3 sites in 2 countries.
Detailed 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 women undergoing screening or diagnostic mammography. Per the new FDA Guidance document for FFDM, accuracy in comparison to Screen-film is no longer required.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesGermany, United States
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartApr 2010
Primary CompletionJan 2011
Study CompletionSep 2011
TodayJul 2026
First PostedOct 22, 2009
Enrollment StartApr 1, 2010
Primary CompletionJan 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.7 years ago