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

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

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

Arm && Interventions

Group	Intervention	Description
Imagio IUS gray-scale ultrasound	Imagio IUS	Imagio gray-scale ultrasound
Imagio OA/US	Imagio OA/US	Imagio OA/US (opto-acoustic+gray-scale ultrasound)
Imagio IUS gray-scale ultrasound	Imagio OA/US	Imagio gray-scale ultrasound
Imagio OA/US	Imagio IUS	Imagio OA/US (opto-acoustic+gray-scale ultrasound)

Primary Outcome Measures

Name	Time	Method
OA/US Sensitivity (Upgrade (%) for BI-RADS 4A & 4B) of Malignant Masses	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.	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.
OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses	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.	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.

Secondary Outcome Measures

Name	Time	Method

Locations (5): Albert Schweitzer Hospital Dordrecht
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Dordrecht, Netherlands
Zorggroep Twente
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Hengelo, Netherlands
Rijnstate Hospital
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Arnhem, Netherlands
Radboud University Nijmegen Medical Centre
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Nijmegen, Netherlands
University Medical Center Utrecht
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Utrecht, Netherlands