N/A
N=217
IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO)
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02364388 ↗Enrolled (actual)
217
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses — 41.1 percentage of masses
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Imagio IUS (Device); Imagio OA/US (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Seno Medical Instruments Inc.
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses |
41.1 | — |
| PRIMARY OA/US Sensitivity (Upgrade (%) for BI-RADS 4A & 4B) of Malignant Masses |
95.5 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02364388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.