Clinical trial NCT03928886: Discomfort Assessment of Senographe Pristina Patient-assisted Versus Standard Compression Mode and Quality Assessment of Screening Mammograms
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mammography Related Discomfort
Keywords: discomfort
patient-assisted compression
breast cancer
screening
mammography
Senographe Pristina
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2019-04-26
Enrollment: 500
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each subject will undergo her regularly scheduled full-field digital mammography imaging exam per standard practices at the investigational site. Study-related compressions will consist of the first and second CC and MLO compressions performed on each breast during each subject's exam. Both the laterality (right/left breast) to which compression modes are assigned and the mode of compression to start with will be randomized across all subjects. Hence, approximately one quarter of women will use patient-assisted compression as first option on the right breast, another quarter will use patient-assisted compression as first option on the left breast, a third quarter will use standard compression as first option on the right breast and the last quarter will use standard compression as first option on the left breast. The randomization schedule will be generated by Epidemiology and Evaluation Department of the Hospital and provided to the study staff prior to start of enrollment.
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

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 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.

Primary outcomes:
measure: Patient discomfort using an 11-point numeric pain rating scale
timeFrame: Immediately following full-field digital mammography breast imaging
Secondary outcomes:
measure: Technical/Clinical quality of mammogram using the PGMI system
timeFrame: Immediately following radiologists analysis
measure: Average glandular dose in mGy
timeFrame: Immediately following full-field digital mammography breast imaging
measure: Breast thickness in mm
timeFrame: Immediately following full-field digital mammography breast imaging
measure: Compression force in daN
timeFrame: Immediately following full-field digital mammography breast imaging
Other outcomes:
measure: Patient experience feedback: Patient preference about patient-assisted compression over standard compression using a 5-point Likert scale
timeFrame: Immediately following full-field digital mammography breast imaging
measure: Patient experience feedback: Patient-assisted compression discomfort as compared to standard compression using a 5-point Likert scale
timeFrame: Immediately following full-field digital mammography breast imaging
measure: Patient experience feedback: Expected comfortability in next screening if patient-assisted compression were available using a 5-point Likert scale
timeFrame: Immediately following full-field digital mammography breast imaging
measure: Patient experience feedback: Patient-assisted compression satisfaction, expressed as the level of agreement to recommend it to friends and family using a 5-point Likert scale
timeFrame: Immediately following full-field digital mammography breast imaging
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar - Parc de Salut Mar
state: Catalonia
Study officials:
affiliation: RAlcantara@parcdesalutmar.cat
name: Rodrigo Alcántara, MD
role: PRINCIPAL_INVESTIGATOR
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