Breast Cancer
Conditions
Keywords
Mammography, Tomosynthesis
Brief summary
The primary objective of this study is to compare the safety and clinical performance of the Philips MicroDose Tomosynthesis system images and images from FFDM systems.
Detailed description
The study will be performed in two phases: Image Accrual and Image Reading. Approximately 800 women who fulfill all inclusion and exclusion criteria will be enrolled in chronological order from up to 3 different US sites with one study investigator for each site. Two cohorts of patients will be enrolled (i.e., Biopsy and Screening Cohorts). Paired sets of a standard 4-view exam will be collected both from Philips Tomosynthesis system (Tomosynthesis and synthetic 2D images) and a FDA-cleared FFDM system. All enrolled cases will be quality controlled for completeness of image and patient information. The reading portion of the study will include approximately 300 normal cases (including some cases determined to be normal after call back after screening mammography), 65 cancer cases, and 40 biopsy proven benign cases. The primary objective of the study is to compare the safety and clinical performance of the Philips MicroDose Tomosynthesis system (Tomosynthesis and synthetic 2D) images to conventional 2D mammography images (FFDM).
Interventions
RADIATIONImaging 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
Sponsors
Philips Digital Mammography Sweden AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is female and at least 40 years of age * No contraindication for routine bilateral mammography Screening Cohort * Patient presents for a routine screening mammogram Biopsy Cohort * Patient is scheduled for a biopsy * Patient has a screening detected abnormality
Exclusion criteria
* Patient is pregnant or believes she may be pregnant; OR, * Patient is breast feeding; OR * Patient is unable or unwilling to give informed consent, including consent to reuse data for future research; OR, * Patient has breast implants; OR * Patient has previous surgical biopsy; OR * Patient has previous breast cancer; OR * Patient presented to screening with clinical symptoms (e.g. palpable lump, nipple discharge, nipple retraction, skin irritation or dimpling)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Compare Average Glandular Dose Between FDDM and Philips Tomosynthesis System | Nine months image accrual |
| Compare Non-cancer Recall Rates Between FDDM and Philips Tomosynthesis System. | Nine months image accrual |
| Compare Sensitivity Between FDDM and Philips Tomosynthesis System, Sensitivity Will be Estimated for Each Reader as the Proportion of Cancer Cases With Per-case BI-RADS Category 4 or Higher. | One year follow up will be performed on negative patients |
| Compare Specificity Between FDDM and Philips Tomosynthesis System. Specificity Will be Estimated by Reader as the Proportion of Non-cancer Cases With Per-case BI-RADS Category Less Than 4. | One year follow up will be performed on negative patients |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 347 |
| Total | 347 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Lost to Follow-up | 134 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Imaging on Experimental Tomo Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 104 Participants |
| Age, Categorical Between 18 and 65 years | 243 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 347 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized African American | 105 Participants |
| Race/Ethnicity, Customized American indian or Alaskan native | 4 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized White | 233 Participants |
| Region of Enrollment United States | 347 Participants |
| Sex: Female, Male Female | 347 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 347 |
| other Total, other adverse events | 0 / 347 |
| serious Total, serious adverse events | 0 / 347 |
Outcome results
Primary
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.
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.
Time frame: Up to approximately 4 weeks.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Imaging on Experimental Tomo Device | 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 |
| Imaging on Experimental Tomo Device | 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 |
| Imaging on Experimental Tomo Device | 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 |
| Imaging on Experimental Tomo Device | 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 |
| Imaging on Experimental Tomo Device | 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
Compare Average Glandular Dose Between FDDM and Philips Tomosynthesis System
Time frame: Nine months image accrual
Population: No data were collected due to study termination.
Secondary
Compare Non-cancer Recall Rates Between FDDM and Philips Tomosynthesis System.
Time frame: Nine months image accrual
Population: No data were collected due to study termination.
Secondary
Compare Sensitivity Between FDDM and Philips Tomosynthesis System, Sensitivity Will be Estimated for Each Reader as the Proportion of Cancer Cases With Per-case BI-RADS Category 4 or Higher.
Time frame: One year follow up will be performed on negative patients
Population: No data were collected due to study termination.
Secondary
Compare Specificity Between FDDM and Philips Tomosynthesis System. Specificity Will be Estimated by Reader as the Proportion of Non-cancer Cases With Per-case BI-RADS Category Less Than 4.
Time frame: One year follow up will be performed on negative patients
Population: No data were collected due to study termination.