Clinical trial · Interventional
Imagio Feasibility Multi-Reader, Multi-Case Study
Imagio Feasibility Multi-Reader, Multi-Case Study of Optoacoustic Images Versus Imagio Ultrasound to Guide Decision to Biopsy
NCT03708393CI-TRIAL-00053127completedN/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)
Controlled, blinded, multi-reader, multi-case study
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imagio (IUS+OA) | Device | — | UNRESOLVED |
| Imagio Ultrasound | Device | — | UNRESOLVED |
| Mammography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Imagio IUS
- description
- Read 1 - Mammo (as available) + Imagio Ultrasound
- interventionNames
- Device: Imagio Ultrasound
- Device: Mammography
- type
- EXPERIMENTAL
- label
- Imagio (IUS+OA)
- description
- Read 2 - Mammo (as available) + (Imagio Ultrasound + OA)
- interventionNames
- Device: Imagio (IUS+OA)
- Device: Mammography
Primary outcomes (1)
- measure
- The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Female subjects participating in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status Exclusion Criteria: \- Female subjects who did not have known clinical status in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status
References
Publications (0)
Data not yet available
No reference posted for this study.