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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
347
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
University of Alabama at Birmingham
Birmingham, Alabama, United States
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.
Compare Average Glandular Dose Between FDDM and Philips Tomosynthesis System
Time frame: Nine months image accrual
Compare Non-cancer Recall Rates Between FDDM and Philips Tomosynthesis System.
Time frame: 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.
Time frame: 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.
Time frame: One year follow up will be performed on negative patients
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