Patient-Assisted Compression - Impact on Image Quality and Workflow

• ClinicalTrials.gov Identifier: NCT03196635
• Recruitment Status: Completed
• First Posted: June 23, 2017
• Results First Posted: August 31, 2018
• Last Update Posted: August 31, 2018
• Sponsor: GE Healthcare
• Information provided by (Responsible Party): GE Healthcare

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Device: Patient-Assisted (PA) Breast Compression; Device: Technologist-Controlled (TC) Breast Compression	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Patient-Assisted Compression - Impact on Image Quality and Workflow
• Actual Study Start Date: June 19, 2017
• Actual Primary Completion Date: June 29, 2017
• Actual Study Completion Date: June 29, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets [ Time Frame: Through study completion, on average 1 month ]
   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.

Secondary Outcome Measures :

1. Repeat Image Acquisition [ Time Frame: Through study completion, on average 1 month ]
   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.
2. Acceptability of Mammographic Attributes [ Time Frame: Through study completion, on average 1 month ]
   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.

Other Outcome Measures:

1. Comparison of Image Acquisition Time [ Time Frame: Through study completion, on average 1 month ]
   The length of time it takes for image acquisition using each compression mode (TC Compression and PA Compression) were compared.
2. Technologist Interventions in PA Compression [ Time Frame: Through study completion, on average 1 month ]
   Data will be collected regarding any interventions made by the technologist during PA compression and this data were summarized.
3. Compression Force for PA and TC Compressions [ Time Frame: Through study completion, on average 1 month ]
   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.
4. Breast Thickness for PA and TC Compressions [ Time Frame: Through study completion, on average 1 month ]
   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.
5. Radiation Dose for PA and TC Compressions [ Time Frame: Through study completion, on average 1 month ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Asymptomatic women, aged 40 years or older scheduled for FFDM screening mammography
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Florida

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

Boca Raton, Florida, United States, 33486

Sponsors and Collaborators

GE Healthcare

Investigators

• Principal Investigator: Kathy Schilling; Boca Raton Regional Hospital

  Study Documents (Full-Text)

Documents provided by GE Healthcare:

Study Protocol and Statistical Analysis Plan  [PDF] May 22, 2017

More Information

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT03196635
• Other Study ID Numbers: 124.03-2017-GES-0002
• First Posted: June 23, 2017
• Results First Posted: August 31, 2018
• Last Update Posted: August 31, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No