Mammography Related DiscomfortNCT03928886
Discomfort Assessment of Senographe Pristina Patient-assisted Versus Standard Compression Mode and Quality Assessment of Screening Mammograms
A study testing bilateral two-view (CC and MLO) FFDM (full field digital mammography) using patient-assisted compression mode and bilateral two-view (CC and MLO) FFDM (full field digital mammography) using standard compression mode in people with Mammography Related Discomfort, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 69 years, women only
- Conditions the study is for
- Mammography Related Discomfort
- What is being tested?
- bilateral two-view (CC and MLO) FFDM (full field digital mammography) using patient-assisted compression mode and bilateral two-view (CC and MLO) FFDM (full field digital mammography) using standard compression mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2017to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital del Mar - Parc de Salut Mar
Barcelona, Catalonia, 08003
Rodrigo Alcántara, MD, 932 48 30 00 ext. 5109/25909, RAlcantara@parcdesalutmar.cat
Xavier Castells, MD PHD
About this study
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.
Read the 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.
- Conditions
- Mammography Related Discomfort
- Being tested
- bilateral two-view (CC and MLO) FFDM (full field digital mammography) using patient-assisted compression mode, bilateral two-view (CC and MLO) FFDM (full field digital mammography) using standard compression mode
- Keywords
- discomfort, patient-assisted compression, breast cancer, screening, mammography, Senographe Pristina
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral two-view (CC and MLO) FFDM (full field digital mammography) using patient-assisted compression modeDevice
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.
bilateral two-view (CC and MLO) FFDM (full field digital mammography) using standard compression modeDevice
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 group | Role | What they receive |
|---|---|---|
| Senographe Pristina patient-assisted compression model | Experimental | 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. Receives: Device: bilateral two-view (CC and MLO) FFDM (full field digital mammography) using patient-assisted compression mode |
| Senographe Pristina standard compression mode (usual care) | Active comparator | Senographe Pristina standard mode Receives: Device: bilateral two-view (CC and MLO) FFDM (full field digital mammography) using standard compression mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient discomfort using an 11-point numeric pain rating scale
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
Measured: Immediately following full-field digital mammography breast imaging
Secondary outcomes (4)
Technical/Clinical quality of mammogram using the PGMI system
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
Measured: Immediately following radiologists analysis
Average glandular dose in mGy
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
Measured: Immediately following full-field digital mammography breast imaging
Breast thickness in mm
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
Measured: Immediately following full-field digital mammography breast imaging
Compression force in daN
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.
Measured: Immediately following full-field digital mammography breast imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start1 Dec 2017
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Mammography Related DiscomfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Rodrigo Alcántara, MD, Principal investigator, RAlcantara@parcdesalutmar.cat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928886
- Sponsor's protocol ID
- 2017-7631
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2019
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
American Cancer Society, "Breast Cancer Facts & Figures 2015-2016," United States, 2015.
Nelson HD, Tyne K, Naik A, Bougatsos C, Chan BK, Humphrey L; U.S. Preventive Services Task Force. Screening for breast cancer: an update for the U.S. Preventive Services Task Force. Ann Intern Med. 2009 Nov 17;151(10):727-37, W237-42. doi: 10.7326/0003-4819-151-10-200911170-00009.
PubMed 19920273Shapiro S, Strax P, Venet L. Periodic breast cancer screening in reducing mortality from breast cancer. JAMA. 1971 Mar 15;215(11):1777-85. No abstract available.
PubMed 5107709Hendrick RE, Smith RA, Rutledge JH 3rd, Smart CR. Benefit of screening mammography in women aged 40-49: a new meta-analysis of randomized controlled trials. J Natl Cancer Inst Monogr. 1997;(22):87-92. doi: 10.1093/jncimono/1997.22.87.
PubMed 9709282Thurfjell EL, Lindgren JA. Breast cancer survival rates with mammographic screening: similar favorable survival rates for women younger and those older than 50 years. Radiology. 1996 Nov;201(2):421-6. doi: 10.1148/radiology.201.2.8888234.
PubMed 8888234Tabar L, Vitak B, Chen HH, Yen MF, Duffy SW, Smith RA. Beyond randomized controlled trials: organized mammographic screening substantially reduces breast carcinoma mortality. Cancer. 2001 May 1;91(9):1724-31. doi: 10.1002/1097-0142(20010501)91:93.0.co;2-v.
PubMed 11335897Swedish Organised Service Screening Evaluation Group. Reduction in breast cancer mortality from organized service screening with mammography: 1. Further confirmation with extended data. Cancer Epidemiol Biomarkers Prev. 2006 Jan;15(1):45-51. doi: 10.1158/1055-9965.EPI-05-0349.
PubMed 16434585Coldman A, Phillips N, Wilson C, Decker K, Chiarelli AM, Brisson J, Zhang B, Payne J, Doyle G, Ahmad R. Pan-Canadian study of mammography screening and mortality from breast cancer. J Natl Cancer Inst. 2014 Oct 1;106(11):dju261. doi: 10.1093/jnci/dju261. Print 2014 Nov.
PubMed 25274578Hofvind S, Ursin G, Tretli S, Sebuodegard S, Moller B. Breast cancer mortality in participants of the Norwegian Breast Cancer Screening Program. Cancer. 2013 Sep 1;119(17):3106-12. doi: 10.1002/cncr.28174. Epub 2013 May 29.
PubMed 23720226Whelehan P, Evans A, Wells M, Macgillivray S. The effect of mammography pain on repeat participation in breast cancer screening: a systematic review. Breast. 2013 Aug;22(4):389-94. doi: 10.1016/j.breast.2013.03.003. Epub 2013 Mar 28.
PubMed 23541681Dullum JR, Lewis EC, Mayer JA. Rates and correlates of discomfort associated with mammography. Radiology. 2000 Feb;214(2):547-52. doi: 10.1148/radiology.214.2.r00fe23547.
PubMed 10671609Gupta R, Nayak M, Khoursheed M, Roy S, Behbehani AI. Pain during mammography: impact of breast pathologies and demographic factors. Med Princ Pract. 2003 Jul-Sep;12(3):180-3. doi: 10.1159/000070756.
PubMed 12766337Poulos A, Rickard M. Compression in mammography and the perception of discomfort. Australas Radiol. 1997 Aug;41(3):247-52. doi: 10.1111/j.1440-1673.1997.tb00668.x.
PubMed 9293675Kornguth PJ, Rimer BK, Conaway MR, Sullivan DC, Catoe KE, Stout AL, Brackett JS. Impact of patient-controlled compression on the mammography experience. Radiology. 1993 Jan;186(1):99-102. doi: 10.1148/radiology.186.1.8416595.
PubMed 8416595de Groot JE, Broeders MJ, Branderhorst W, den Heeten GJ, Grimbergen CA. Mammographic compression after breast conserving therapy: controlling pressure instead of force. Med Phys. 2014 Feb;41(2):023501. doi: 10.1118/1.4862512.
PubMed 24506652
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03928886
- Acronym / sponsor ID
- 2017-7631
- Conditions
- Mammography Related Discomfort
- Keywords
- discomfort, patient-assisted compression, breast cancer, screening, mammography, Senographe Pristina
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Senographe Pristina patient-assisted compression model | Experimental | Device: bilateral two-view (CC and MLO) FFDM (full field digital mammography) using patient-assisted compression modeSenographe 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. |
| Senographe Pristina standard compression mode (usual care) | Active comparator | Device: bilateral two-view (CC and MLO) FFDM (full field digital mammography) using standard compression modeSenographe Pristina standard mode |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bilateral two-view (CC and MLO) FFDM (full field digital mammography) using patient-assisted compression modePatient-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 | Senographe Pristina patient-assisted compression model |
| bilateral two-view (CC and MLO) FFDM (full field digital mammography) using standard compression modeStandard 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. | Device | Senographe Pristina standard compression mode (usual care) |
Primary outcome
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
4 secondary outcomes
Technical/Clinical quality of mammogram using the PGMI system
Time frame: Immediately following radiologists analysis
Average glandular dose in mGy
Time frame: Immediately following full-field digital mammography breast imaging
Breast thickness in mm
Time frame: Immediately following full-field digital mammography breast imaging
Compression force in daN
Time frame: Immediately following full-field digital mammography breast imaging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- BackgroundAmerican Cancer Society, "Breast Cancer Facts & Figures 2015-2016," United States, 2015.
- Background: PubMed 19920273Nelson HD, Tyne K, Naik A, Bougatsos C, Chan BK, Humphrey L; U.S. Preventive Services Task Force. Screening for breast cancer: an update for the U.S. Preventive Services Task Force. Ann Intern Med. 2009 Nov 17;151(10):727-37, W237-42. doi: 10.7326/0003-4819-151-10-200911170-00009.
- Background: PubMed 5107709Shapiro S, Strax P, Venet L. Periodic breast cancer screening in reducing mortality from breast cancer. JAMA. 1971 Mar 15;215(11):1777-85. No abstract available.
- Background: PubMed 9709282Hendrick RE, Smith RA, Rutledge JH 3rd, Smart CR. Benefit of screening mammography in women aged 40-49: a new meta-analysis of randomized controlled trials. J Natl Cancer Inst Monogr. 1997;(22):87-92. doi: 10.1093/jncimono/1997.22.87.
- Background: PubMed 8888234Thurfjell EL, Lindgren JA. Breast cancer survival rates with mammographic screening: similar favorable survival rates for women younger and those older than 50 years. Radiology. 1996 Nov;201(2):421-6. doi: 10.1148/radiology.201.2.8888234.
- Background: PubMed 11335897Tabar L, Vitak B, Chen HH, Yen MF, Duffy SW, Smith RA. Beyond randomized controlled trials: organized mammographic screening substantially reduces breast carcinoma mortality. Cancer. 2001 May 1;91(9):1724-31. doi: 10.1002/1097-0142(20010501)91:93.0.co;2-v.
- Background: PubMed 16434585Swedish Organised Service Screening Evaluation Group. Reduction in breast cancer mortality from organized service screening with mammography: 1. Further confirmation with extended data. Cancer Epidemiol Biomarkers Prev. 2006 Jan;15(1):45-51. doi: 10.1158/1055-9965.EPI-05-0349.
- Background: PubMed 25274578Coldman A, Phillips N, Wilson C, Decker K, Chiarelli AM, Brisson J, Zhang B, Payne J, Doyle G, Ahmad R. Pan-Canadian study of mammography screening and mortality from breast cancer. J Natl Cancer Inst. 2014 Oct 1;106(11):dju261. doi: 10.1093/jnci/dju261. Print 2014 Nov.
- Background: PubMed 23720226Hofvind S, Ursin G, Tretli S, Sebuodegard S, Moller B. Breast cancer mortality in participants of the Norwegian Breast Cancer Screening Program. Cancer. 2013 Sep 1;119(17):3106-12. doi: 10.1002/cncr.28174. Epub 2013 May 29.
- Background: PubMed 23541681Whelehan P, Evans A, Wells M, Macgillivray S. The effect of mammography pain on repeat participation in breast cancer screening: a systematic review. Breast. 2013 Aug;22(4):389-94. doi: 10.1016/j.breast.2013.03.003. Epub 2013 Mar 28.
- Background: PubMed 10671609Dullum JR, Lewis EC, Mayer JA. Rates and correlates of discomfort associated with mammography. Radiology. 2000 Feb;214(2):547-52. doi: 10.1148/radiology.214.2.r00fe23547.
- Background: PubMed 12766337Gupta R, Nayak M, Khoursheed M, Roy S, Behbehani AI. Pain during mammography: impact of breast pathologies and demographic factors. Med Princ Pract. 2003 Jul-Sep;12(3):180-3. doi: 10.1159/000070756.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Alcántara, MD principal investigator
RAlcantara@parcdesalutmar.cat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilateral two-view (CC and MLO) FFDM (full field digital mammography) using patient-assisted compression mode and bilateral two-view (CC and MLO) FFDM (full field digital mammography) using standard compression mode in people with Mammography Related Discomfort, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo Alcántara, MD (932 48 30 00 ext. 5109/25909, RAlcantara@parcdesalutmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient discomfort using an 11-point numeric pain rating scale (time frame: Immediately following full-field digital mammography breast imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03928886, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.