Clinical trial · Interventional
Clinical Data Collection in Breast Tomosynthesis (COBRIS)
Clinical Data Collection in Breast Tomosynthesis: COBRIS
NCT05914168CI-TRIAL-00067341COBRISunknownN/AClinicalTrials.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)
The purpose of the study is to assess an image acquisition application for breast tomosynthesis in a clinical environment
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Tomosynthesis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study arm
- description
- Subjects with investigational acquisition
- interventionNames
- Device: Breast Tomosynthesis
Primary outcomes (1)
- measure
- Data Collection
- timeFrame
- 1 year
- description
- Collect clinical breast images obtained with the investigational application.
Secondary outcomes (1)
- measure
- Assessment of Image Quality
- timeFrame
- 1 year
- description
- Assess image quality through subjective and open expert evaluation of patient motion, visibility of replication artefacts and visibility of clinical findings.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 35 years or older; * Women referred for unilateral or bilateral 2D and 3D mammography; * Women able and willing to comply with study procedures; * Women able and willing to participate in this study who have signed and dated the informed consent form; and * Women surgically sterile or postmenopausal or, the possibility of pregnancy is ruled out based on a negative urine pregnancy test Exclusion Criteria: * Women who have been previously included in this study; or * Be a minor, protected adult, adult deprived of liberty by judicial or administrative decision, pregnant, parturient or a breastfeeding mother; or * Women with BRCA 1 or BRCA 2 gene mutation
References
Publications (0)
Data not yet available
No reference posted for this study.