CONFIDENCE Registry

Study Overview
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Brief Summary
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This registry has been designed to obtain real-life, post-market data on the use of the Imagio breast imaging system. This registry is sponsored by Seno Medical Instruments, Inc., the manufacturer of the device.

Detailed Description
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This is a prospective, controlled, multi-center, observational international registry designed to evaluate the Imagio breast imaging system. The registry will be conducted at up to 12 international centers. Investigators will use Imagio US (IUS) and/or Imagio OA/US imaging per standard of care, anddata will be collected accordingly. Additional imaging and biopsy/surgery will be conducted per standard of care to reach a final diagnosis.

Official Title
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A Multi-Center InternatiONal Registry to Evaluate the Efficacy oF Imaging With Opto-acoustics to Diagnose BrEast CaNCEr

Conditions
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Breast Abnormality Diagnosis

Intervention / Treatment
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* Device: Imagio OA/US


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - Subjects must meet all the following criteria to be included in the registry: Have been informed of the nature of the registry and provided written informed consent, prior to initiation of any registry activities, Are females 18 years of age or older at the time of consent, Have been referred for a breast US and are subject to treatment with the Imagio breast imaging system. Exclusion Criteria - Aligned with the contraindications on the use of the device, subjects who meet any of the following criteria will be excluded from the registry: Are pregnant. Have open sores including insect bites, rash, poison ivy, and chafing on the skin of the ipsilateral breast. Are experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline. Are currently undergoing phototherapy. Have a history of any photosensitive disease (e.g., porphyria, lupus erythematosus). Are undergoing treatment for a photosensitive disease and is experiencing photosensitivity. Have previously participated in this registry, Are currently enrolled in another investigational study or registry that would directly interfere with the current registry.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Imagio OA/US<br>Imagio optoacoustic | Device: Imagio OA/US<br>* Imagio optoacoustic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity, negative likelihood ratio, sensitivity and positive likelihood | This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations | September 2024 | 
| Assessment of the percentage of masses that the Imagio system alone or in combination with other imaging modalities is indicated as impacting the decision to biopsy | This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations | September 2024 | 
| Quality of Life Assessment - Testing Morbidity Index | This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations | September 2024 | 
| In malignant breast masses, to assess the roles of the Imagio OA/US as a prognostic biomarker | i.e., the correlation of Imagio OA/US feature scoring with histologic grade, ER and PR hormone receptors, HER2 receptor (IHC and/or HER2 FISH), Ki-67 proliferative index, as well as with molecular subtypes of breast cancer. This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations | September 2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of lymph node lesions/masses the device is used for | This parameter will be reviewed for the Safety population | September 2024 | 
| Incidence and nature of device deficiencies (i.e. device complaints, device malfunctions) | This parameter will be reviewed for the Safety population | September 2024 | 
| Incidence and nature of device and procedure related adverse events | This parameter will be reviewed for the Safety population | September 2024 |