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

Seno Medical Instruments Inc.217 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

217

Conditions

Breast Cancer

Interventions

Imagio IUSDEVICE

Imagio diagnostic gray-scale ultrasound

Imagio OA/USDEVICE

Diagnostic opto-acoustic +gray-scale ultrasound

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Rijnstate Hospital

Arnhem, Netherlands

Albert Schweitzer Hospital Dordrecht

Dordrecht, Netherlands

Zorggroep Twente

Hengelo, Netherlands

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Outcomes

Primary Outcomes

OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses

Outcome is the percentage of benign masses correctly downgraded by (OA/US) ultrasonography from a suspicious abnormality (4A or 4B) to benign or probably benign (BI-RADS 2 or 3). BI-RADS is the Breast Imaging Reporting and Data System established the American College of Radiology. BI-RADS scores range from 0 to 6, with increase in score indicating an increase in the probability of malignancy. A BI-RADS score of 4 or more indicates the need for biopsy. Specificity is reported with a 96% confidence interval using a normal approximation.

Time frame: CDU images and decision to biopsy to be done at Screening. OA/US imaging to be done within 10 days of Screening. Biopsy to be done within 30 days of Screening.

OA/US Sensitivity (Upgrade (%) for BI-RADS 4A & 4B) of Malignant Masses

Outcome is the percentage of malignant masses correctly identified by (OA/US) ultrasonography as BI-RADS 4a or higher. BI-RADS is the Breast Imaging Reporting and Data System established the American College of Radiology. BI-RADS scores range from 0 to 6, with increase in score indicating an increase in the probability of malignancy. A BI-RADS score of 4 or more indicates the need for biopsy. Sensitivity is reported with a 96% confidence interval using a normal approximation.

Time frame: CDU images and decision to biopsy to be done at Screening. OA/US imaging to be done within 10 days of Screening. Biopsy to be done within 30 days of Screening.

Data from ClinicalTrials.gov

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