Patient-Assisted Compression in 3D - Impact on Image Quality and Workflow (3D PAC)

Patient-assisted compression (PAC) allows the patient to participate in controlling the amount of compression force during mammography and is a personalized approach that has demonstrated successful reduction in discomfort experienced during mammography. General Electric Healthcare's Senographe Pristina, an innovative mammography platform that provides both two-dimensional (2D) and three-dimensional (3D) imaging capabilities, offers both standard and patient-assisted compression modes. This study will evaluate image quality and clinical workflow as it relates to use of PAC with the Senographe Pristina 3D.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Patient-Assisted Compression (PAC); Device: Technologist-Controlled (TC) Compression

Detailed Description

The study population will consist of adult asymptomatic women presenting for screening 2D mammography. One breast of each subject will be identified as the "breast of interest," which will undergo study-specific 3D imaging consisting of two-view (craniocaudal and mediolateral oblique) PA compression and image acquisition, followed by two-view technologist-controlled (TC) compression and image acquisition. The breast of interest will be randomly assigned to either the first breast imaged during the exam or the second breast imaged. TC compression and imaging, and procedures performed on the subject's other breast will be conducted per standard of care.

Following image acquisition, 3D image quality evaluation will be conducted by Mammography Quality Standards Act-qualified readers. Prior to the reading session, images will be de-identified and the following information will be removed from the DICOM header to blind readers to the compression mode used during acquisition: time stamp, compression force, and breast thickness. The image sets will also be randomized for presentation during the image attribute reviews. Two (2) readers will evaluate each PAC and TC compression image set collected from each subject's breast of interest and assess the acceptability of image attributes, as defined in the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full-Field Digital Mammography System (2012). A third reader will provide adjudication, if there is disagreement for a given image set's overall clinical image quality.

Workflow data, including the incidence of technologist intervention during acquisition and need for repeat image acquisition, will also be collected.

The proportion of PAC image sets that are of equal or higher acceptability than TC image sets will be calculated. A 95% confidence interval will be calculated using asymptotic method with continuity correction. The proportion of image sets indicated for repeated image acquisition when using PA mode or TC mode will be summarized. Other endpoint data will be summarized using descriptive statistics. No statistical hypothesis is being tested in this study.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Are women aged 40 years or older;
2. Are asymptomatic and scheduled for screening mammography;
3. Have left and right breasts;
4. Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;
5. Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;
6. Are able and willing to comply with study procedures; and
7. Are able and willing to provide written informed consent to participate.

Exclusion Criteria:

1. Are women aged 40 years or older;
2. Are asymptomatic and scheduled for screening mammography;
3. Have left and right breasts;
4. Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;
5. Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;
6. Are able and willing to comply with study procedures; and
7. Are able and willing to provide written informed consent to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: All Study Participants; All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.

Device: Patient-Assisted Compression (PAC); The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views Craniocaudal (CC) & Mediolateral Oblique (MLO).; Device: Technologist-Controlled (TC) Compression; TC compression will be conducted per standard of care practices at the site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Acceptable Overall Image Quality	The primary objective is to compare the percentage of acceptable overall image quality in unilateral two-view (CC and MLO) breast images acquired using Patient-Assisted Compression and Technologist Compression modes.	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Repeat Image Acquisitions	To evaluate the need for repeat image acquisition when using Patient-Assisted Compression and Technologist Compression modes.	1 Day
Percentage of Acceptable Mammographic Attributes	To evaluate the percentage of acceptable mammographic attributes for unilateral two-view breast images acquired using Patient-Assisted Compression and Technologist Compression modes.	1 Day

Collaborators and Investigators

• Sponsor: GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2018
• Primary Completion (Actual): January 9, 2018
• Study Completion (Actual): January 9, 2018

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: January 9, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 124.03-2017-GES-0005

Drug and device information, study documents

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