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: New 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): 515

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
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • 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
• Genders Eligible for Study: Female

• 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
Screening Patients; 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; X-ray imaging of breast tissue
Diagnostic Patients; 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; X-ray imaging of breast tissue

What is the study measuring?

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)

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 15, 2020
• Last Update Submitted That Met QC Criteria: May 13, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Breast Cancer; Tomosynthesis; 3D Mammogram; Diagnostic Mammogram
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; 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