At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle
In Brief
An observational study evaluating Standard of Care Flat Paddle and Investigational Curved Paddle for Breast Cancer. Completed, enrolled 443 participants across 4 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
X-Ray Mammogram Exam. Each screening subject will receive a 4-view 2D plus 3D combination imaging: Left Cranial Caudal (LCC), Left Medial Oblique (LMO), Right Cranial Caudal (RCC), and Right Medial Oblique (RMLO) with the current standard of care (SOC) flat paddle. Each diagnostic subject will have her prescribed diagnostic 2D plus 3D combination imaging (CC or MLO) with the SOC flat paddle. The image view (CC or MLO) will be based on the visibility of the area of interest for which the diagnostic imaging was ordered. The amount of compression applied in all mammograms will be to achieve tautness.
X-Ray Mammogram Exam. Each screening subject will receive a CC and an MLO in one of her breasts as determined by a randomization scheme with the investigational (INV) curved paddle. Each diagnostic subject will have her prescribed diagnostic 2D plus 3D combination imaging (CC or MLO) with the INV curved paddle. The image view (CC or MLO) will be based on the visibility of the area of interest for which the diagnostic imaging was ordered. The amount of compression applied in all mammograms will be to achieve tautness.