Trial Outcomes & Findings for Image Evaluation of Philips Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM) (NCT NCT00999596)
NCT ID: NCT00999596
Last Updated: 2012-12-04
Results Overview
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.
COMPLETED
107 participants
Day 1
2012-12-04
Participant Flow
Recruitment was initiated at out primary Diagnostic site in April 2010 and concluded in February 2011. A total of 35 diagnostic cases were obtained. Recruitment was initiated at out primary Screening site in May 2010 and concluded in November 2011. A total of 67 screening cases were obtained.
The trial was to evaluate performance of a FFDM system. During image acquisition FDA modified the trial criteria from an efficacy trial to a SE trial. Images from our diag site prior to Nov could not be used in this study as mag views were now required. Mag views were acquired in Jan-Feb 2011. Selected images were used from our screen site.
Participant milestones
| Measure |
FFDM (Full Field Digital Mammography)
Mammograms from the Philips Digital System
|
|---|---|
|
Overall Study
STARTED
|
107
|
|
Overall Study
New FDA Guideline Released
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
101
|
Reasons for withdrawal
| Measure |
FFDM (Full Field Digital Mammography)
Mammograms from the Philips Digital System
|
|---|---|
|
Overall Study
Statistical population not required
|
101
|
Baseline Characteristics
Image Evaluation of Philips Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)
Baseline characteristics by cohort
| Measure |
FFDM (Full Field Digital Mammography)
n=107 Participants
Mammograms from the Philips Digital System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
107 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
104 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: This was not a statistical sample per FDA FFDM Guideline. FDA Guideline specified that a minimum of 6 film sets from the participants be analyzed. The number of participants required by FDA changed mid-study.
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.
Outcome measures
| Measure |
FFDM Mammograms Score = Pass
n=6 Participants
Mammogram sets from the Philips Digital System with Pass score for Image Quality
|
FFDM Mammograms Score = Fail
n=6 Participants
Mammogram sets from the Philips Digital System with Fail score for Image Quality
|
|---|---|---|
|
FFDM (Full Field Digital Mammography) Mammogram Scores
|
12 FFDM Mammogram set
|
0 FFDM Mammogram set
|
Adverse Events
FFDM (Full Field Digital Mammography)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sarah Baxter or Linda Jalbert
Philips Healthcare
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60