Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle

Study Overview
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Brief Summary
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The goal of this study is to evaluate patient comfort during compression with a standard flat mammographic paddle and an investigational curved paddle. This is a study that will be performed with x-ray imaging and will be used to determine if an overall reduction in pain can be appreciated in patients without loss in image quality as compared to the current standard mammogram. Another benefit of the curved paddle may be an increase of perceivable and measurable tissue capture.

Detailed Description
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The study will be conducted in the United States at up to 5 centers. The study will enroll up to 600 subjects. The number of subjects was chosen to allow evaluation of screening and diagnostic patients with a variety of breast densities (fatty, scattered densities, heterogeneously dense or extremely dense) and women with a range of breasts sizes that fit on the current detector. The evaluation of pain reduction will be the primary endpoint, while examining the potential of increased tissue capture without a compromise in image quality will be assessed as secondary endpoints. The enrollment will be consecutive for subjects who sign informed consent to participate. Women participating in the study will present for a screening or diagnostic imaging exam.

Official Title
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Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: New investigational curved paddle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is female of any race and ethnicity Screening Subject is at least 40 years old, Diagnostic subjects are at least 25 years old Subject will be referred for a screening or a diagnostic work-up with tomosynthesis as part of the exam Exclusion Criteria: Subjects who are pregnant or who think they may be pregnant Subjects lactating or presenting with discharge Women too large for the detector Subjects who cannot give informed consent

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Screening Patients<br>100 Patients. Each patient who agrees to participate and is consented and is undergoing a routine screening mammogram will receive her normal 4 view 2D plus 3D combination imaging (Left Cranial Caudal (LCC), Left Mediolateral-Oblique (LMO), Right Cranial Caudal (RCC), Right Mediolateral-Oblique (RMLO)) mammogram, with the current standard paddle. In addition she will also receive a CC and a MLO in one of her breasts as determined by a randomization scheme with the new investigational curved paddle. The amount of compression applied to both mammograms will be that to achieve tautness. | Device: New investigational curved paddle<br>* X-ray imaging of breast tissue<br>|
| Diagnostic Patients<br>400 Patients. Patients who agree to participate, are consented and are undergoing a diagnostic exam will have her prescribed diagnostic 2D plus 3D combination imaging as well as a CC or MLO with both the standard paddle and the new investigational curved paddle compressed to tautness on the breast of interest. The order of the paddles will be randomized and the view (CC or MLO) will be based in the visibility of the area of interest for which the diagnostic imaging was ordered. (It is possible that one of the views is superior to assess the area of interest). | Device: New investigational curved paddle<br>* X-ray imaging of breast tissue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Comfort | Score of 1-10 on Universal Pain Assessment Tool | Day of Procedure (No Follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue Volume | Acceptable/Non-Acceptable determination on tissue coverage | Day of Procedure (No Follow-up) | 
| Image quality | Acceptable/Non-Acceptable determination on overall image quality | Day of Procedure (No Follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Tomosynthesis, 3D Mammogram, Diagnostic Mammogram