Clinical trial · Interventional
Patient-Assisted Compression - Impact on Image Quality and Workflow
NCT03196635CI-TRIAL-00034667completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is being conducted to compare the image quality of breast images obtained using standard (technologist-controlled \[TC\]) compression and patient-assisted (PA) compression and to evaluate the impact of PA compression on clinical workflow.
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 (PA) Breast Compression | Device | — | UNRESOLVED |
| Technologist-Controlled (TC) Breast Compression | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All Study Participants
- description
- All subjects will undergo their regularly scheduled full-field digital mammogram, consisting of bilateral, 2-view (craniocaudal \[CC\] and mediolateral oblique \[MLO\]) image acquisition. In addition, a study-specific, unilateral 2-view image set will obtained, utilizing the PA breast compression mode.
- interventionNames
- Device: Patient-Assisted (PA) Breast Compression
- Device: Technologist-Controlled (TC) Breast Compression
Primary outcomes (1)
- measure
- Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets
- timeFrame
- Through study completion, on average 1 month
- description
- One PA image set and one TC image set was acquired from each completed subject. The overall clinical image quality acceptability was collected and summarized on a per subject-basis using binary responses of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets. Two readers evaluated each of the 60 image sets (30 PA and 30 TC compression image sets from 30 completed participants). In cases of disagreement between Readers 1 and 2, a third reader provided adjudication.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Are women aged 40 years or older; * Are asymptomatic and scheduled for FFDM screening mammography; * Have left and right breasts; * Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off; * 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; and * 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 reconstruction, within five (5) years (≤ 5 years) of the study exam date; * Are currently undergoing radiotherapy or chemotherapy, or have a history of prior radiotherapy treatment on either breast; * Are currently lactating; or * Have breast implants.
References
Publications (0)
Data not yet available
No reference posted for this study.