Discomfort Assessment of Senographe Pristina Patient-assisted Versus Standard Compression Mode in Asymptomatic Adult Women Undergoing Screening Full-filled Digital Mammography and Quality Evaluation of Screening Mammograms
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Patient discomfort using an 11-point numeric pain rating scale
研究概览
简要总结
Senographe Pristina is a new mammography system (hardware and software) designed to improve patient experience, patient throughput, and radiographer experience while maintaining the imaging capabilities and image quality of full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) breast imaging. The purpose of this study is to assess patient experience as it relates to discomfort when patient-assisted compression is compared against the standard compression mode of Senographe Pristina in asymptomatic adult women undergoing screening FFDM mammography.
The technical/clinical quality assessment of mammograms is essential to ensure that high quality images are consistently used in a breast cancer screening program. Advances in mammography equipment may improve the image quality. Therefore, the investigators hypothesize that the introduction of Senographe Pristina may have an effect on the technical/clinical quality of screening mammograms.
详细描述
Leading authorities on breast cancer recommend regular screening mammography for women aged 40 years and older as a means of early detection for breast cancer, which can lead to increased survival rates and more treatment options. Numerous randomized trials have demonstrated that regular mammographic screening reduces breast cancer mortality, with more than 40% reduction in breast cancer deaths. Amidst the success of screening mammography, clinicians struggle to maintain patient participation in regular screening programs. Notably, a systematic review by Whelehan, et al. concluded that pain experienced during screening mammography (e.g. compression pain) contributed to reduced rates of repeat participation in regular screening programs.
Adequate breast compression during mammography creates uniform thickness and flattens tissues, which is necessary to obtain sufficient image quality and reduce radiation dose. Various methods are being investigated to maintain sufficient compression while reducing pain associated with mammography. Specifically, studies have shown that a personalized approach to compression can significantly reduce pain intensity and discomfort experienced by patients while maintaining diagnostic image quality.
Patient-controlled compression allows the patient to control the amount of compression force during mammography and is a personalized approach that has demonstrated successful pain reduction in mammography. GE Healthcare's Senographe Pristina, an innovative mammography platform that provides both two-dimensional (2D) and three-dimensional (3D) imaging capabilities, offers standard and patient-controlled compression modes. The study described herein is being conducted to compare discomfort experienced by asymptomatic women undergoing full-field digital (FFDM) 2D screening mammography with standard and patient-controlled compression modes of Senographe Pristina. Results from this study may be used to support future regulatory submissions.
The population of this study will consist of adult asymptomatic women presenting for screening FFDM. Eligible patients will be enrolled and will undergo bilateral two-view (CC and MLO) imaging with Senographe Pristina.
Each subject will use both standard and patient-assisted compression modes, with one mode randomly assigned to the right breast and the other mode assigned to the left breast. Immediately following image acquisition (i.e. during decompression), subjects will be asked to rate their level of discomfort using a validated 11-point pain rating scale (numeric rating scale). Additional data collected from each subject will include demographic and clinical history information, breast thickness, radiation dose, compression force, and overall patient experience feedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women participating in their subsequent round in the breast cancer screening program
- •Asymptomatic women scheduled for full-field digital screening mammography
- •Have left and right breasts
- •Have breast sizes compatible with the dimensions of a 24x29 cm image detector without anatomical cut-off
- •Are able to provide subjective pain scores, per verbal self-report
- •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
- •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 mastectomy, or reconstruction;
- •Are currently undergoing radiotherapy or chemotherapy, or have a history of prior radiotherapy treatment on either breast;
- •Are currently lactating
- •Have breast implants.
研究组 & 干预措施
Senographe Pristina patient-assisted compression model
Senographe Pristina is a commercial mammography medical device consisting of the Senographe Pristina FFDM system (2D) and Senographe Pristina DBT option (3D). Senographe Pristina includes the hardware and software components required for multi-modality functioning and is designed to improve patient experience, patient throughput, and radiographer experience. The system offers two compression modes - standard mode and the optional patient-assisted compression. The patient-assisted compression feature enables the patient to personally refine breast compression using a hand-held remote control after the compression has been initiated by the operator, which is required to ensure proper breast positioning.
干预措施: bilateral two-view (CC and MLO) FFDM (full field digital mammography) using patient-assisted compression mode (Device)
Senographe Pristina standard compression mode (usual care)
Senographe Pristina standard mode
干预措施: bilateral two-view (CC and MLO) FFDM (full field digital mammography) using standard compression mode (Device)
结局指标
主要结局
Patient discomfort using an 11-point numeric pain rating scale
时间窗: Immediately following full-field digital mammography breast imaging
Subject-provided pain scores using an 11-point numeric rating scale (NRS) of patient-assisted compression and standard compression will be used as a measure of discomfort. A total of six (6) pain scores will be obtained from each subject, consisting of two (2) baseline pain scores (right/left breast) collected previous to the image acquisition, two (2) patient-assisted compression scores (CC and MLO) and two (2) standard compression scores (CC and MLO). Immediately following image acquisition (i.e. during decompression of the breast), study staff will ask the subject to provide a verbal score, indicating her level of pain for the given compression. A validated 11-point NRS will be used for each assessment, where a score of 0 will indicate no pain and 10 will indicate the worst pain. Pain scores will be documented on Case Report Form (CRFs) by the study staff
次要结局
- Average glandular dose in mGy(Immediately following full-field digital mammography breast imaging)
- Compression force in daN(Immediately following full-field digital mammography breast imaging)
- Technical/Clinical quality of mammogram using the PGMI system(Immediately following radiologists analysis)
- Breast thickness in mm(Immediately following full-field digital mammography breast imaging)