Clinical trial · Interventional
Discomfort Assessment of Senographe Pristina Patient-assisted Versus Standard Compression Mode and Quality Assessment of Screening Mammograms
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mammography Related Discomfort | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bilateral two-view (CC and MLO) FFDM (full field digital mammography) using patient-assisted compression mode | Device | — | UNRESOLVED |
| bilateral two-view (CC and MLO) FFDM (full field digital mammography) using standard compression mode | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Senographe Pristina patient-assisted compression model
- description
- 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.
- interventionNames
- Device: bilateral two-view (CC and MLO) FFDM (full field digital mammography) using patient-assisted compression mode
- type
- ACTIVE_COMPARATOR
- label
- Senographe Pristina standard compression mode (usual care)
- description
- Senographe Pristina standard mode
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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.
References
Publications (21)
- BACKGROUNDAmerican Cancer Society, "Breast Cancer Facts & Figures 2015-2016," United States, 2015.
- BACKGROUNDNelson 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. PMID 19920273
- BACKGROUNDShapiro 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. PMID 5107709
- BACKGROUNDHendrick 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. PMID 9709282
- BACKGROUNDThurfjell 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. PMID 8888234
- BACKGROUNDTabar 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. PMID 11335897
- BACKGROUNDSwedish 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. PMID 16434585
- BACKGROUNDColdman 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.