Clinical trial · Interventional
IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO)
NCT02364388CI-TRIAL-00044497MAESTROcompletedN/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)
Imagio breast imaging system, is an opto-acoustic (OA) imaging system designed to concurrently collect images in conjunction with diagnostic ultrasound ( co-registered OA and B-mode imaging). This medical device has CE-marking and is approved for use in Europe and other nations. This is a post-market, non-randomized multi-center surveillance 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imagio IUS | Device | — | UNRESOLVED |
| Imagio OA/US | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Imagio IUS gray-scale ultrasound
- description
- Imagio gray-scale ultrasound
- interventionNames
- Device: Imagio IUS
- Device: Imagio OA/US
- type
- OTHER
- label
- Imagio OA/US
- description
- Imagio OA/US (opto-acoustic+gray-scale ultrasound)
- interventionNames
- Device: Imagio IUS
- Device: Imagio OA/US
Primary outcomes (2)
- measure
- OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Female * 18 years of age or older * Have an undiagnosed suspicious finding which may include more than one solid or complex cystic suspicious mass, classified by CDU as BI-RADS 4a or 4b within 3 weeks of their baseline Imagio Scan Exclusion Criteria: * Have a condition or impediment that could interfere with the intended field of view (within one probe length or 4 cm of the mass), (i.e., breast implants within the previous 12 months, or tattoos) * Pregnant or lactating * Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU
References
Publications (0)
Data not yet available
No reference posted for this study.