Patient-Assisted Compression - Impact on Image Quality and Workflow

NCT03196635 | Completed Results FDA Device

• 1 other identifier: 124.03-2017-GES-0002
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Repeat Image Acquisition

  Through study completion, on average 1 month

• Acceptability of Mammographic Attributes

  Through study completion, on average 1 month

Other Outcomes (5)

• Comparison of Image Acquisition Time

  Through study completion, on average 1 month

• Technologist Interventions in PA Compression

  Through study completion, on average 1 month

• Compression Force for PA and TC Compressions

  Through study completion, on average 1 month

Study Arms (1)

All Study Participants

EXPERIMENTAL

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; Device: Technologist-Controlled (TC) Breast Compression

Interventions

Patient-Assisted (PA) Breast Compression 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.

All Study Participants

Technologist-Controlled (TC) Breast Compression DEVICE

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

All Study Participants

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Asymptomatic women, aged 40 years or older scheduled for FFDM screening mammography
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

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

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: Sara Lam
• Organization: GE Healthcare

sara.j.lam@ge.com

262-548-2369

Study Officials

• Kathy Schilling

  Boca Raton Regional Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 23, 2017
• Study Start: June 19, 2017
• Primary Completion: June 29, 2017
• Study Completion: June 29, 2017
• Last Updated: August 31, 2018
• Results First Posted: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)