Patient-Assisted Compression - Impact on Image Quality and Workflow
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets
时间窗: 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.
次要结局
- Acceptability of Mammographic Attributes(Through study completion, on average 1 month)
- Repeat Image Acquisition(Through study completion, on average 1 month)