N/A
N=31
Patient-Assisted Compression - Impact on Image Quality and Workflow
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03196635 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets — 30; 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient-Assisted (PA) Breast Compression (Device); Technologist-Controlled (TC) Breast Compression (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- GE Healthcare
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets |
30; 30 | — |
| SECONDARY Repeat Image Acquisition |
2; 7; 4; 4 | — |
| SECONDARY Acceptability of Mammographic Attributes |
30; 29; 30; 30; 30; 30 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03196635). 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.