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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03928886
Recruitment Status Recruiting
First Posted April 26, 2019
Last update posted April 26, 2019
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.
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. Pain scores will be summarized with descriptive statistics and other endpoint data will be analyzed using general statistical methods. Pain results will be compared according to compression mode and multivariate analysis will be performed to assess the potential effect of other variables. The technical/clinical quality assessment of mammograms is essential to ensure that high quality images are consistently used in a breast cancer screening program. Poor image quality may lead to missed diagnoses and compromised detection of breast cancers. In this sense, it has been reported that high image quality leads to higher detection rates and fewer interval cancers. In order to assess the technical/clinical quality of screening mammograms, the PGMI (perfect, good, moderately good, and inadequate) system will be used. With this system the investigators routinely evaluate the technical/clinical quality of screening mammograms in our center. A random sample of 500 women with two (2) Medio Lateral Oblique (MLO) and two (2) Cranial Caudal (CC) views produced with Senographe Pristina (291 with patient-assisted compression and 291 with standard compression mode) will be assessed by three highly trained radiologists. Technical/clinical image quality will be compared according to compression mode and multivariate analysis will be performed to assess the potential effect of other variables. Additionally, the investigators will compare the technical/clinical image quality of mammograms produced by Senographe Pristina with the image quality observed in the previous routine evaluations performed in our center.
|Experimental: 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.
Device: bilateral two-view (CC and MLO) FFDM (full field digital mammography) using patient-assisted compression mode
Patient-assisted mode of Senographe Pristina (a commercial mammography medical device consisting of the Senographe Pristina FFDM system -2D- and Senographe Pristina DBT option -3D-) for FFDM imaging procedure. 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.
|Active Comparator: Senographe Pristina standard compression mode (usual care)
Senographe Pristina standard mode
Device: bilateral two-view (CC and MLO) FFDM (full field digital mammography) using standard compression mode
Standard compression mode of Senographe Pristina (a commercial mammography medical device consisting of the Senographe Pristina FFDM system -2D- and Senographe Pristina DBT option -3D-) for FFDM imaging procedure. Study-related compressions will consist of the first and second CC and MLO compressions performed on each breast during each subject's exam.
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- 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
- 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
- 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.
Contact: Rodrigo Alcántara, MD 932 48 30 00 ext 5109/25909 RAlcantara@parcdesalutmar.cat
Hospital del Mar - Parc de Salut Mar
Parc de Salut Mar
Principal Investigator: Rodrigo Alcántara, MD RAlcantara@parcdesalutmar.cat
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