Mammography Related Discomfort Clinical Trial
Official title:
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
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.
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