Clinical trial · Interventional
Patient-Assisted Compression in 3D - Impact on Image Quality and Workflow
- 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)
Patient-assisted compression (PAC) allows the patient to participate in controlling the amount of compression force during mammography and is a personalized approach that has demonstrated successful reduction in discomfort experienced during mammography. General Electric Healthcare's Senographe Pristina, an innovative mammography platform that provides both two-dimensional (2D) and three-dimensional (3D) imaging capabilities, offers both standard and patient-assisted compression modes. This study will evaluate image quality and clinical workflow as it relates to use of PAC with the Senographe Pristina 3D.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient-Assisted Compression (PAC) | Device | — | UNRESOLVED |
| Technologist-Controlled (TC) Compression | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- All Study Participants
- description
- All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.
- interventionNames
- Device: Patient-Assisted Compression (PAC)
- Device: Technologist-Controlled (TC) Compression
Primary outcomes (1)
- measure
- Percentage of Acceptable Overall Image Quality
- timeFrame
- 1 Day
- description
- The primary objective is to compare the percentage of acceptable overall image quality in unilateral two-view (CC and MLO) breast images acquired using Patient-Assisted Compression and Technologist Compression modes.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Are women aged 40 years or older; 2. Are asymptomatic and scheduled for screening mammography; 3. Have left and right breasts; 4. Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off; 5. 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; 6. Are able and willing to comply with study procedures; and 7. Are able and willing to provide written informed consent to participate. Exclusion Criteria: 1. Are women aged 40 years or older; 2. Are asymptomatic and scheduled for screening mammography; 3. Have left and right breasts; 4. Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off; 5. 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; 6. Are able and willing to comply with study procedures; and 7. Are able and willing to provide written informed consent to participate.
References
Publications (0)
Data not yet available