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Discomfort Assessment of Senographe Pristina Patient-assisted Versus Standard Compression Mode and Quality Assessment of Screening Mammograms

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ClinicalTrials.gov Identifier: NCT03928886
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Parc de Salut Mar

Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE December 1, 2017
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
Patient discomfort using an 11-point numeric pain rating scale [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Technical/Clinical quality of mammogram using the PGMI system [ Time Frame: Immediately following radiologists analysis ]
    Two highly trained radiologists will independently assess the quality of the images according to the PGMI system (Perfect, Good, Moderate, Inadequate). In case of disagreement, a third radiologist will assess the quality and a final score will reach by majority. All participating radiologists will be blind to the compression status. Items taken into account for the PGMI are: (i) For CC view: Nipple not in profile, skin folds, images not symmetrical, medial border of the breast not seen, axillary tail of the breast insufficiently seen, inadequate compression/blur, artefacts and incorrect annotation/labeling.(ii) For MLO view: insufficient inframammary angle, nipple not in profile, images not symmetrical, pectoralis major muscle not to nipple level, pectoralis major muscle not at appropriate angle, inadequate compression/blur, and artefacts. Technical/Clinical quality of mammogram using the PGMI system will be documented on CRF by the study staff
  • Average glandular dose in mGy [ Time Frame: Immediately following full-field digital mammography breast imaging ]
    Average glandular dose is provided systematically by the mammography device following image acquisition. Results are expressed in miligray (mGy). Average glandular dose will be documented on CRF by the study staff
  • Breast thickness in mm [ Time Frame: Immediately following full-field digital mammography breast imaging ]
    Breast thickness is provided systematically by the mammography device following image acquisition. Results are expressed in milimeters (mm). Breast thickness will be documented on CRF by the study staff
  • Compression force in daN [ Time Frame: Immediately following full-field digital mammography breast imaging ]
    Compression force is provided systematically by the mammography device following image acquisition. Results are expressed in decanewton (daN). Compression force will be documented on CRF by the study staff.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 23, 2019)
  • Patient experience feedback: Patient preference about patient-assisted compression over standard compression using a 5-point Likert scale [ Time Frame: Immediately following full-field digital mammography breast imaging ]
    Study staff will provide an online questionnaire to each of the subjects when their imaging exams are completed. Subjects will complete the questionnaires while still at the site, and a member of the study staff will be available to address any questions. The questionnaire will consist of four (4) items, structured as statements and answered using a 5-point Likert scale: 1. Strongly agree, 2. Agree; 3. Neither agree nor disagree; 4. Disagree; 5. Strongly disagree. This item's statement is as follows: I preferred the patient-assisted compression exam over the standard compression exam
  • Patient experience feedback: Patient-assisted compression discomfort as compared to standard compression using a 5-point Likert scale [ Time Frame: Immediately following full-field digital mammography breast imaging ]
    Study staff will provide an online questionnaire to each of the subjects when their imaging exams are completed. Subjects will complete the questionnaires while still at the site, and a member of the study staff will be available to address any questions. The questionnaire will consist of four (4) items, structured as statements and answered using a 5-point Likert scale: 1. Strongly agree, 2. Agree; 3. Neither agree nor disagree; 4. Disagree; 5. Strongly disagree. This item's statement is as follows: The patient-assisted compression screening exam caused less discomfort than the standard compression exam
  • Patient experience feedback: Expected comfortability in next screening if patient-assisted compression were available using a 5-point Likert scale [ Time Frame: Immediately following full-field digital mammography breast imaging ]
    Study staff will provide an online questionnaire to each of the subjects when their imaging exams are completed. Subjects will complete the questionnaires while still at the site, and a member of the study staff will be available to address any questions. The questionnaire will consist of four (4) items, structured as statements and answered using a 5-point Likert scale: 1. Strongly agree, 2. Agree; 3. Neither agree nor disagree; 4. Disagree; 5. Strongly disagree. This item's statement is as follows: I would feel more comfortable going to my next breast screening exam if patient-assisted compression were available
  • 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 [ Time Frame: Immediately following full-field digital mammography breast imaging ]
    Study staff will provide an online questionnaire to each of the subjects when their imaging exams are completed. Subjects will complete the questionnaires while still at the site, and a member of the study staff will be available to address any questions. The questionnaire will consist of four (4) items, structured as statements and answered using a 5-point Likert scale: 1. Strongly agree, 2. Agree; 3. Neither agree nor disagree; 4. Disagree; 5. Strongly disagree. This item's statement is as follows: I would recommend a patient-assisted compression exam to my friends and family
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Discomfort Assessment of Senographe Pristina Patient-assisted Versus Standard Compression Mode and Quality Assessment of Screening Mammograms
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE Mammography Related Discomfort
Intervention  ICMJE
  • 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.
  • 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.

Study Arms  ICMJE
  • 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.
    Intervention: Device: bilateral two-view (CC and MLO) FFDM (full field digital mammography) using patient-assisted compression mode
  • Active Comparator: Senographe Pristina standard compression mode (usual care)
    Senographe Pristina standard mode
    Intervention: Device: bilateral two-view (CC and MLO) FFDM (full field digital mammography) using standard compression mode
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rodrigo Alcántara, MD 932 48 30 00 ext 5109/25909 RAlcantara@parcdesalutmar.cat
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03928886
Other Study ID Numbers  ICMJE 2017-7631
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Parc de Salut Mar
Study Sponsor  ICMJE Parc de Salut Mar
Collaborators  ICMJE GE Healthcare
Investigators  ICMJE
Principal Investigator: Rodrigo Alcántara, MD RAlcantara@parcdesalutmar.cat
PRS Account Parc de Salut Mar
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP