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

NCT03456427 | Completed Results FDA Device

• 1 other identifier: 124.03-2017-GES-0005
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Repeat Image Acquisitions

  1 Day

• Percentage of Acceptable Mammographic Attributes

  1 Day

Study Arms (1)

All Study Participants

OTHER

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); Device: Technologist-Controlled (TC) Compression

Interventions

Patient-Assisted Compression (PAC) DEVICE

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).

All Study Participants

Technologist-Controlled (TC) Compression DEVICE

TC compression will be conducted per standard of care practices at the site.

All Study Participants

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are women aged 40 years or older;
• Are asymptomatic and scheduled for screening mammography;
• Have left and right breasts;
• Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;
• 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;
• Are able and willing to comply with study procedures; and
• Are able and willing to provide written informed consent to participate.

You may not qualify if:

• Are women aged 40 years or older;
• Are asymptomatic and scheduled for screening mammography;
• Have left and right breasts;
• Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;
• 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;
• Are able and willing to comply with study procedures; and
• Are able and willing to provide written informed consent to participate.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Beth Heckel
• Organization: GE Healthcare

beth.heckel@med.ge.com

1-262-312-7269

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 7, 2018
• Study Start: January 4, 2018
• Primary Completion: January 9, 2018
• Study Completion: January 9, 2018
• Last Updated: April 5, 2019
• Results First Posted: April 5, 2019

Record last verified: 2019-01

Locations

US (1)