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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Imagio IUS
* Device: Imagio OA/US


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Imagio IUS gray-scale ultrasound<br>Imagio gray-scale ultrasound | Device: Imagio IUS<br>* Imagio diagnostic gray-scale ultrasound<br>* Other names: gray-scale ultrasound;Device: Imagio OA/US<br>* Diagnostic opto-acoustic +gray-scale ultrasound<br>* Other names: Imagio opto-acoustic + gray-scale ultrasound;|
| Other: Imagio OA/US<br>Imagio OA/US (opto-acoustic+gray-scale ultrasound) | Device: Imagio IUS<br>* Imagio diagnostic gray-scale ultrasound<br>* Other names: gray-scale ultrasound;Device: Imagio OA/US<br>* Diagnostic opto-acoustic +gray-scale ultrasound<br>* Other names: Imagio opto-acoustic + gray-scale ultrasound;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast imaging diagnosis, breast ultrasound, Imagio, Seno Medical Instruments, Inc., Seno, opto-acoustics, OA