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

Seno Medical

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Imagio OA/US; Device: Imagio IUS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02364388

MAESTRO-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 217 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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217 participants in 2 patient groups

Imagio IUS gray-scale ultrasound

Active Comparator group

Description:

Imagio gray-scale ultrasound

Treatment:

Device: Imagio IUS

Device: Imagio OA/US

Imagio OA/US

Other group

Description:

Imagio OA/US (opto-acoustic+gray-scale ultrasound)

Treatment:

Device: Imagio IUS

Device: Imagio OA/US