Comparison of the Philips MicroDose Tomosynthesis System to 2D Digital Mammography

Not Applicable

Terminated

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).

Recruitment & Eligibility

Inclusion Criteria

Screening Cohort

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)

Arm && Interventions

Group	Intervention	Description
Imaging on experimental tomo device	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 Non-cancer Recall Rates Between FDDM and Philips Tomosynthesis System.	Nine months image accrual
Compare Average Glandular Dose Between FDDM and Philips Tomosynthesis System	Nine months image accrual
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