Clinical trial NCT03196635: Patient-Assisted Compression - Impact on Image Quality and Workflow
Official title: Patient-Assisted Compression - Impact on Image Quality and Workflow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2017-06-23
Enrollment: 31
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets
timeFrame: Through study completion, on average 1 month
Secondary outcomes:
measure: Repeat Image Acquisition
timeFrame: Through study completion, on average 1 month
measure: Acceptability of Mammographic Attributes
timeFrame: Through study completion, on average 1 month
Other outcomes:
measure: Comparison of Image Acquisition Time
timeFrame: Through study completion, on average 1 month
measure: Technologist Interventions in PA Compression
timeFrame: Through study completion, on average 1 month
measure: Compression Force for PA and TC Compressions
timeFrame: Through study completion, on average 1 month
measure: Breast Thickness for PA and TC Compressions
timeFrame: Through study completion, on average 1 month
measure: Radiation Dose for PA and TC Compressions
timeFrame: Through study completion, on average 1 month
Locations:
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute
state: Florida
Study officials:
affiliation: Boca Raton Regional Hospital
name: Kathy Schilling
role: PRINCIPAL_INVESTIGATOR
References: