N/A
N=36
Patient-Assisted Compression in 3D - Impact on Image Quality and Workflow
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03456427 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Percentage of Acceptable Overall Image Quality — 30; 33; 3; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient-Assisted Compression (PAC) (Device); Technologist-Controlled (TC) Compression (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- GE Healthcare
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Acceptable Overall Image Quality |
30; 33; 3; 0 | — |
| SECONDARY Number of Repeat Image Acquisitions |
1; 0; 32; 33; 3; 3 | — |
| SECONDARY Percentage of Acceptable Mammographic Attributes |
29; 32; 4; 1; 33; 33 | — |
Summary
Patient-assisted compression (PAC) 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. General Electric Healthcare's Senographe Pristina, an innovative mammography platform that provides both two-dimensional (2D) and three-dimensional (3D) imaging capabilities, offers both standard and patient-assisted compression modes. This study will evaluate image quality and clinical workflow as it relates to use of PAC with the Senographe Pristina 3D.
Eligibility Criteria
Inclusion Criteria
- Are women aged 40 years or older;
- Are asymptomatic and scheduled for 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
- Are women aged 40 years or older;
- Are asymptomatic and scheduled for 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.
Data sourced from ClinicalTrials.gov (NCT03456427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.