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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

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.


Condition or disease Intervention/treatment Phase
Mammography Related Discomfort Device: bilateral two-view (CC and MLO) FFDM (full field digital mammography) using patient-assisted compression mode Device: bilateral two-view (CC and MLO) FFDM (full field digital mammography) using standard compression mode Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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
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
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.


Other Outcome Measures:
  1. 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


  2. 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


  3. 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


  4. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928886


Contacts
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Contact: Rodrigo Alcántara, MD 932 48 30 00 ext 5109/25909 RAlcantara@parcdesalutmar.cat

Locations
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Spain
Hospital del Mar - Parc de Salut Mar Recruiting
Barcelona, Catalonia, Spain, 08003
Contact: Rodrigo Alcántara, MD    932 48 30 00 ext 5109/25909    RAlcantara@parcdesalutmar.cat   
Sub-Investigator: Xavier Castells, MD PHD         
Sub-Investigator: Francesc Maciá, MD         
Sub-Investigator: Margarita Posso, MD PHD         
Sub-Investigator: Marta Román, PHD         
Sub-Investigator: Mario Martin-Sanchez, MD         
Sub-Investigator: Ana Rodríguez-Arana, MD         
Sub-Investigator: Juan Martínez, MD         
Sub-Investigator: Natalia Arenas, MD         
Sub-Investigator: Jose Maiques, MD         
Sub-Investigator: Belén Ejarque, Rx tech.         
Sub-Investigator: Mónica Arranz, Rx tech.         
Sponsors and Collaborators
Parc de Salut Mar
GE Healthcare
Investigators
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Principal Investigator: Rodrigo Alcántara, MD RAlcantara@parcdesalutmar.cat

Publications:
American Cancer Society, "Breast Cancer Facts & Figures 2015-2016," United States, 2015.
S. Hofvind, "Quality assurance of mammograms in the Norwegian Breast Cancer Screening Program.," European Journal of Radiology, 2009.
M. Boyce, "Comparing the use and interpretation of PGMI scoring to assess the technical quality of screening mammograms in the UK and Norway," Radiography, 2015.

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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT03928886     History of Changes
Other Study ID Numbers: 2017-7631
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Parc de Salut Mar:
discomfort
patient-assisted compression
breast cancer
screening
mammography
Senographe Pristina