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

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 Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Standard of Care Flat Paddle; Device: Investigational Curved Paddle

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 443

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Stamford, Connecticut, United States, 06902
      • Stamford Hospital
  • New York
    • Rochester, New York, United States, 14620
      • Elizabeth Wende Breast Clinic
  • Texas
    • Addison, Texas, United States, 75001
      • Solis Mammagroaphy
    • Houston, Texas, United States, 77090
      • TOPS Comprehensive Breast Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women participating in the study will present for a screening or diagnostic imaging breast exam.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
STANDARD OF CARE; All the subjects enrolled in this study will be under a routine screening mammogram or undergoing a diagnostic mammogram using the standard of care (SOC) flat paddle. The Universal Pain Assessment Tool (UPAT) will be used to determine the comfort perception of each subject with the SOC paddle. The UPAT ranges from 0 to 10, where 0 represents 'no pain' and 10 'worst pain possible'.	Device: Standard of Care Flat Paddle; 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.
INVESTIGATIONAL; All the subjects enrolled in this study will be under a routine screening mammogram or undergoing a diagnostic mammogram using the investigational (INV) curved paddle. The Universal Pain Assessment Tool (UPAT) will be used to determine the comfort perception of each subject with the INV paddle. The UPAT ranges from 0 to 10, where 0 represents 'no pain' and 10 'worst pain possible'.	Device: Investigational Curved Paddle; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Comfort	The Universal Pain Assessment Tool (UPAT) was used to assess each subject's comfort perception with each paddle (SOC and INV). The UPAT ranges from 0 to 10, where 0 represents 'no pain' and 10 'worst pain possible'.	1 day (Day of procedure, No follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast Tissue Coverage	An expert technologist evaluated the performance of the SOC and the INV paddles in 388 subjects. For each participant, the technologist answered which paddle was better at pulling in more breast tissue during imaging between SOC and INV (all subjects were imaged with both paddles during the same session). The technologist rated the paddles using a 5-point Likert scale, where -2 and -1 values mean that the SOC paddle performed better or slightly better, 0 means equal performance between paddles, and 2 and 1 mean that the INV performed better or slightly better than the SOC paddle. Note that different technologists were involved in the image acquisition. An acceptable tissue coverage for this study refers to having sufficient breast tissue (a balance between fatty and glandular tissue) in the image acquired so that any potential abnormalities can be effectively identified.	1 Day (Day of procedure, No Follow-up)
Overall Determination of Image Quality	An expert radiologist reviewed, side by side, 3D images acquired with the INV and the SOC paddles in 420 subjects. The radiologist rated the images using a 5-point Likert scale, where -2 and -1 values mean that the images acquired with the SOC paddle have better or slightly better quality, 0 means equal quality between the images, and 2 and 1 mean that the images acquired with the INV paddle have better or slightly better quality than the SOC paddle. To determine overall clinical image quality or image acceptability, the radiologist considered whether the images reviewed have fair lesion visibility (when a lesion is present), good breast tissue separations of structures, good breast tissue coverage, no artifacts due to patient motion, and can be used to determine breast tissue density. Note that not all the 420 images were reviewed by the same radiologist.	1 day (Day of procedure, No Follow-up)

Collaborators and Investigators

• Sponsor: Hologic, Inc.
• Investigators: Study Director: Muhammad Waqas, Hologic, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2016
• Primary Completion (Actual): June 18, 2018
• Study Completion (Actual): June 18, 2018

Study Registration Dates

• First Submitted: October 20, 2016
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Breast Cancer; Tomosynthesis; 3D Mammogram; Diagnostic Mammogram
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 16-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No