Patient-Assisted Compression - Impact on Image Quality and Workflow

NCT ID: NCT03196635

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-19
• Study Completion Date: 2017-06-29

Brief Summary

This study is being conducted to compare the image quality of breast images obtained using standard (technologist-controlled [TC]) compression and patient-assisted (PA) compression and to evaluate the impact of PA compression on clinical workflow.

Detailed Description

Patient-assisted (PA) compression 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. GE Healthcare's Senographe Pristina, an innovative mammography platform that provides both two-dimensional (2D) and three-dimensional (3D) imaging capabilities, offers both standard and PA compression modes. This study is being conducted to compare the image quality of breast images obtained using TC compression and PA compression, and to evaluate the impact of PA compression on clinical workflow. The study population will consist of adult asymptomatic women presenting for screening 2D mammography.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

All Study Participants

All subjects will undergo their regularly scheduled full-field digital mammogram, consisting of bilateral, 2-view (craniocaudal \[CC\] and mediolateral oblique \[MLO\]) image acquisition. In addition, a study-specific, unilateral 2-view image set will obtained, utilizing the PA breast compression mode.

Group Type: EXPERIMENTAL

Patient-Assisted (PA) Breast Compression

Intervention Type: 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 CC \& MLO.

Technologist-Controlled (TC) Breast Compression

Intervention Type: DEVICE

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

Interventions

Patient-Assisted (PA) Breast Compression

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 CC \& MLO.

Intervention Type: DEVICE

Technologist-Controlled (TC) Breast Compression

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Are women aged 40 years or older;
• Are asymptomatic and scheduled for FFDM 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.

Exclusion Criteria

• Have been previously included in this study or are participating in another study expected to interfere with study procedures or outcomes;
• Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including breast biopsy, lumpectomy, or reconstruction, within five (5) years (≤ 5 years) of the study exam date;
• Are currently undergoing radiotherapy or chemotherapy, or have a history of prior radiotherapy treatment on either breast;
• Are currently lactating; or
• Have breast implants.

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathy Schilling

Role: PRINCIPAL_INVESTIGATOR

Boca Raton Regional Hospital

Locations

Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute

Boca Raton, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

124.03-2017-GES-0002

Identifier Type: -

Identifier Source: org_study_id