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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Imaging on experimental tomo device


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Imaging on experimental tomo device<br>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. | Radiation: Imaging on experimental tomo device<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to approximately 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mammography, Tomosynthesis