Patient-Assisted Compression - Impact on Image Quality and Workflow

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.

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute

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:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.; Device: Technologist-Controlled (TC) Breast 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
Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets	One PA image set and one TC image set was acquired from each completed subject. The overall clinical image quality acceptability was collected and summarized on a per subject-basis using binary responses of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets. Two readers evaluated each of the 60 image sets (30 PA and 30 TC compression image sets from 30 completed participants). In cases of disagreement between Readers 1 and 2, a third reader provided adjudication.	Through study completion, on average 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeat Image Acquisition	Number of incidences per image set when the technologists or readers indicated a repeat acquisition for PA and TC compression modes. More than one incident (i.e. reason for repeat from technologist or view indicated for repeat by readers) could have been selected for a given image set.	Through study completion, on average 1 month
Acceptability of Mammographic Attributes	Acceptability of mammographic attributes using a binary response of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets were summarized.	Through study completion, on average 1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Image Acquisition Time	The length of time it takes for image acquisition using each compression mode (TC Compression and PA Compression) were compared.	Through study completion, on average 1 month
Technologist Interventions in PA Compression	Data will be collected regarding any interventions made by the technologist during PA compression and this data were summarized.	Through study completion, on average 1 month
Compression Force for PA and TC Compressions	Compression forces (decanewton [daN]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.	Through study completion, on average 1 month
Breast Thickness for PA and TC Compressions	Breast thickness (millimeter [mm]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.	Through study completion, on average 1 month
Radiation Dose for PA and TC Compressions	Radiation dose (entrance skin air kerma [ESAK] in milligray [mGy]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.	Through study completion, on average 1 month

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Kathy Schilling, Boca Raton Regional Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Actual): June 29, 2017
• Study Completion (Actual): June 29, 2017

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 23, 2017

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 124.03-2017-GES-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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