NCT02364388

IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Seno Medical Instruments Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a post-market surveillance study that is prospective, controlled, multi-center, to evaluate if Imagio OA can downgrade BI-RADS ( Breast Imaging-Reporting and Data System) classification following CDU (Conventional Diagnostic Ultrasound) for the visualization and characterization of suspicious masses prior to core needle biopsy (CNB) or excision. Investigators will perform CDU to reach a diagnosis and decision to biopsy. Imagio OA will not be used as the reason to perform or to defer a CNB (Core Needle Biopsy) or excision.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Imagio IUS	Imagio diagnostic gray-scale ultrasound
DEVICE	Imagio OA/US	Diagnostic opto-acoustic +gray-scale ultrasound

Timeline

• Start date: 2015-03-27
• Primary completion: 2016-02-15
• Completion: 2016-02-15
• First posted: 2015-02-18
• Last updated: 2020-04-06
• Results posted: 2020-04-06

Locations

5 sites across 1 country: Netherlands