Clinical trial · Observational
Image Evaluation of Philips Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)
Clinical Image Evaluation Study for Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)
NCT00999596CI-TRIAL-00008585completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- FFDM (Full Field Digital Mammography)
- description
- Mammograms from the Philips Digital System
Primary outcomes (1)
- measure
- FFDM (Full Field Digital Mammography) Mammogram Scores
- timeFrame
- Day 1
- description
- 6 mammography image sets (4 images per set) from women participating in the study were read and rated (pass/fail) by 2 MQSA (Mammorgraphy Quality Standards Act) certified mammography readers. A typical MQSA evaluation was performed on each image set and an image set was scored Pass or Fail. A total of 12 scores (6 image sets, 2 readers) were obtained.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. At least 40 years of age 3. Provides written informed consent indicating willingness to participate in this research study prior to performance of the Philips FFDM mammogram 4. Meets none of the exclusion criteria Exclusion Criteria: 1. Presence of a breast implant, 2. Patients undergoing a unilateral mammogram or an incomplete SF mammogram 3. had previously undergone an excisional breast biopsy 4. 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
References
Publications (0)
Data not yet available
No reference posted for this study.