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

• ClinicalTrials.gov Identifier: NCT03611543
• Recruitment Status: Completed
• First Posted: August 2, 2018
• Last Update Posted: May 15, 2020
• Sponsor: Hologic, Inc.
• Information provided by (Responsible Party): Hologic, Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Breast Cancer	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 Design

• Study Type: Observational
• Actual Enrollment: 515 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle
• Actual Study Start Date: October 20, 2016
• Actual Primary Completion Date: June 18, 2018
• Actual Study Completion Date: June 18, 2018

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Patient Comfort [ Time Frame: Day of Procedure (No Follow-up) ]
   Score of 1-10 on Universal Pain Assessment Tool

Secondary Outcome Measures :

1. Tissue Volume [ Time Frame: Day of Procedure (No Follow-up) ]
   Acceptable/Non-Acceptable determination on tissue coverage
2. Image quality [ Time Frame: Day of Procedure (No Follow-up) ]
   Acceptable/Non-Acceptable determination on overall image quality

Eligibility Criteria

• Ages Eligible for Study: 25 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• 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.

Criteria

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

Contacts and Locations

Locations

United States, Connecticut

Stamford Hospital

Stamford, Connecticut, United States, 06902

United States, New York

Elizabeth Wende Breast Clinic

Rochester, New York, United States, 14620

United States, Ohio

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

United States, Texas

Solis Mammagroaphy

Addison, Texas, United States, 75001

TOPS Comprehensive Breast Center

Houston, Texas, United States, 77090

Sponsors and Collaborators

Hologic, Inc.

Investigators

• Study Director: Muhammad Waqas; Hologic, Inc.

More Information

• Responsible Party: Hologic, Inc.
• ClinicalTrials.gov Identifier: NCT03611543
• Other Study ID Numbers: 16-03
• First Posted: August 2, 2018
• Last Update Posted: May 15, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hologic, Inc.:

Breast Cancer; Tomosynthesis; 3D Mammogram; Diagnostic Mammogram

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases