Trial Outcomes & Findings for Comparison of the Philips MicroDose Tomosynthesis System to 2D Digital Mammography (NCT NCT02615509)
NCT ID: NCT02615509
Last Updated: 2020-05-08
Results Overview
Due to study termination the conventional images where not taken and it was not possible to calculate the Area under the Receiver Operating Characteristics Curve. Instead we are reporting the biopsy results from the Philips MicroDose Tomosynthesis system. The time frame from examination to biopsy is documented as an estimate based on the relative urgency to detect potential tumors.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
347 participants
Primary outcome timeframe
Up to approximately 4 weeks.
Results posted on
2020-05-08
Participant Flow
Participant milestones
| Measure |
Imaging on Experimental Tomo Device
Women will have a bilateral two-view mammogram (a total of four images) with the Philips MicroDose Tomosynthesis system and a bilateral two-view mammogram (a total of four images) with an FFDM system. The order of this will be randomised.
After collecting the cases together with ground truth a readers study will be performed.
Imaging on experimental tomo device: The system used for imaging in the experimental arm is the Philips MicroDose tomography system. The system used for imaging in the active comparator is a standard FFDM system
|
|---|---|
|
Overall Study
STARTED
|
347
|
|
Overall Study
COMPLETED
|
201
|
|
Overall Study
NOT COMPLETED
|
146
|
Reasons for withdrawal
| Measure |
Imaging on Experimental Tomo Device
Women will have a bilateral two-view mammogram (a total of four images) with the Philips MicroDose Tomosynthesis system and a bilateral two-view mammogram (a total of four images) with an FFDM system. The order of this will be randomised.
After collecting the cases together with ground truth a readers study will be performed.
Imaging on experimental tomo device: The system used for imaging in the experimental arm is the Philips MicroDose tomography system. The system used for imaging in the active comparator is a standard FFDM system
|
|---|---|
|
Overall Study
Lost to Follow-up
|
134
|
|
Overall Study
Death
|
4
|
|
Overall Study
Withdrawal by Subject
|
8
|
Baseline Characteristics
Comparison of the Philips MicroDose Tomosynthesis System to 2D Digital Mammography
Baseline characteristics by cohort
| Measure |
Imaging on Experimental Tomo Device
n=347 Participants
Women will have a bilateral two-view mammogram (a total of four images) with the Philips MicroDose Tomosynthesis system and a bilateral two-view mammogram (a total of four images) with an FFDM system. The order of this will be randomised.
After collecting the cases together with ground truth a readers study will be performed.
Imaging on experimental tomo device: The system used for imaging in the experimental arm is the Philips MicroDose tomography system. The system used for imaging in the active comparator is a standard FFDM system
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
243 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
347 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
347 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American indian or Alaskan native
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
105 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
233 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
347 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 4 weeks.Due to study termination the conventional images where not taken and it was not possible to calculate the Area under the Receiver Operating Characteristics Curve. Instead we are reporting the biopsy results from the Philips MicroDose Tomosynthesis system. The time frame from examination to biopsy is documented as an estimate based on the relative urgency to detect potential tumors.
Outcome measures
| Measure |
Imaging on Experimental Tomo Device
n=347 Participants
Women will have a bilateral two-view mammogram (a total of four images) with the Philips MicroDose Tomosynthesis system and a bilateral two-view mammogram (a total of four images) with an FFDM system. The order of this will be randomised.
After collecting the cases together with ground truth a readers study will be performed.
Imaging on experimental tomo device: The system used for imaging in the experimental arm is the Philips MicroDose tomography system. The system used for imaging in the active comparator is a standard FFDM system
|
|---|---|
|
To Compare the Clinical Performance of the Philips MicroDose Tomosynthesis System Images to Conventional 2D Mammography Images. Clinical Performance Will be Based on the Area Under the Receiver Operating Characteristics Curve.
Biopsy proven benign
|
15 Participants
|
|
To Compare the Clinical Performance of the Philips MicroDose Tomosynthesis System Images to Conventional 2D Mammography Images. Clinical Performance Will be Based on the Area Under the Receiver Operating Characteristics Curve.
Biopsy proven cancer
|
14 Participants
|
|
To Compare the Clinical Performance of the Philips MicroDose Tomosynthesis System Images to Conventional 2D Mammography Images. Clinical Performance Will be Based on the Area Under the Receiver Operating Characteristics Curve.
Negative recalled
|
31 Participants
|
|
To Compare the Clinical Performance of the Philips MicroDose Tomosynthesis System Images to Conventional 2D Mammography Images. Clinical Performance Will be Based on the Area Under the Receiver Operating Characteristics Curve.
Negative, no recall
|
279 Participants
|
|
To Compare the Clinical Performance of the Philips MicroDose Tomosynthesis System Images to Conventional 2D Mammography Images. Clinical Performance Will be Based on the Area Under the Receiver Operating Characteristics Curve.
Withdrawn
|
8 Participants
|
SECONDARY outcome
Timeframe: Nine months image accrualPopulation: No data were collected due to study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Nine months image accrualPopulation: No data were collected due to study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One year follow up will be performed on negative patientsPopulation: No data were collected due to study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One year follow up will be performed on negative patientsPopulation: No data were collected due to study termination.
Outcome measures
Outcome data not reported
Adverse Events
Imaging on Experimental Tomo Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place