IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO) (MAESTRO)
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|ClinicalTrials.gov Identifier: NCT02364388|
Recruitment Status : Completed
First Posted : February 18, 2015
Last Update Posted : October 21, 2016
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Device: Imagio Scan|
|Study Type :||Observational|
|Actual Enrollment :||217 participants|
|Official Title:||IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO)|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|