NCT03611543

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

Completed Results posted Last updated 21 May 2025

What this trial tests

trial testing Standard of Care Flat Paddle in Breast Cancer in 443 participants. Completed in 18 June 2018.

Timeline

20 October 2016

Primary endpoint
18 June 2018

18 June 2018

Quick facts

Lead sponsor	Hologic, Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	443
Start date	20 October 2016
Primary completion	18 June 2018
Estimated completion	18 June 2018
Sites	4 locations across United States

Drugs / interventions tested

• Standard of Care Flat Paddle
• Investigational Curved Paddle

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Hologic, Inc.

Who can join

25 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Subject Comfort Primary · 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'.

Group	Value	95% CI
INVESTIGATIONAL	2.6	2.3 – 2.6
STANDARD OF CARE	4.0	3.6 – 4.1

Breast Tissue Coverage Secondary · 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

Rate -2 or -1 (SOC better or slightly better than INV)

Group	Value	95% CI
All Enrolled Subjects	69

Rate 0 ( SOC equal INV)

Group	Value	95% CI
All Enrolled Subjects	162

Rate 2 or 1 ( INV better or slightly better than SOC)

Group	Value	95% CI
All Enrolled Subjects	157

Overall Determination of Image Quality Secondary · 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 vis

Rate -2 or -1 (SOC better or slightly better than INV)

Group	Value	95% CI
All Enrolled Subjects	27

Rate 0 (SOC equal INV)

Group	Value	95% CI
All Enrolled Subjects	330

Rate 2 or 1 (INV better or slightly better than SOC)

Group	Value	95% CI
All Enrolled Subjects	63

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.