IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO) (MAESTRO)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO)|
- To evaluate if Imagio OA technology downgrades BI-RADS 4a and 4b classification as indicated by CDU to 3 or 2 for benign masses and to evaluate if Imagio OA technology does not lower BI-RADS classification from 4a to 4b as determined by CDU to 3 or 2 [ Time Frame: 8.5 months ]
|Study Start Date:||March 2015|
|Study Completion Date:||July 2016|
|Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Female subjects that 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.
Device: Imagio Scan
The Imagio breast imaging system is indicated for use by a qualified and trained healthcare provider for opto-acoustic (OA) evaluation of breasts in women who are referred for a diagnostic breast ultrasound work-up due to a suspicious mass (including both palpable and non-palpable) or an imaging finding such as mammographic mass, architectural distortion, asymmetry or suspicious calcifications.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02364388
|Arnhem, Netherlands, 6815 AD|
|Hengelo, Netherlands, 7555 DL|
|Radboud University Nijmegen Medical Centre|
|Nijmegen, Netherlands, 6500 HB|
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3508 GA|