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

Completed

Conditions: Breast Cancer

Registration Number: NCT03611543

Lead Sponsor: Hologic, Inc.

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 443

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subject Comfort	1 day (Day of procedure, No follow-up)	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'.

Secondary Outcome Measures

Name	Time	Method
Breast Tissue Coverage	1 Day (Day of procedure, No Follow-up)	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.
Overall Determination of Image Quality	1 day (Day of procedure, No Follow-up)	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.

Trial Locations

Locations (4): Stamford Hospital
🇺🇸
Stamford, Connecticut, United States
Elizabeth Wende Breast Clinic
🇺🇸
Rochester, New York, United States
Solis Mammagroaphy
🇺🇸
Addison, Texas, United States
TOPS Comprehensive Breast Center
🇺🇸
Houston, Texas, United States
Stamford Hospital
🇺🇸Stamford, Connecticut, United States