Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System

Study Overview
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Brief Summary
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This study performs the first clinical evaluation of the Gen 2 Imagio System in a clinical setting to assess image quality with both the IUS ultrasound only probe and the OA/US (duplex probe).

Detailed Description
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Obtain ultrasound only probe images and duplex probe OA/US (both gray scale and OA) probe images. This includes doppler and elastography imaging with the gray scale only ultrasound probe and ultrasound mode of the duplex OA/US probe. Provide breast and lymph node pathology results (except BI-RADS 1, 2 and 3 (as applicable))

Official Title
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Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System

Conditions
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Breast Cancer Stage

Intervention / Treatment
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* Device: Imagio


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a signed and dated informed consent, prior to initiation of any study-related activities. Is at least 18 years of age. Have been referred for a breast US because of a breast lesion/mass finding via a palpable lump or per standard of care imaging. Is willing and able to comply with protocol-required scans Exclusion Criteria: Is pregnant or lactating. Has a condition or breast impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, hematoma, nipple rings, etc.) which could interfere with the intended field of view. Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as some sulfur containing drugs, ampicillin, tetracycline. Is currently undergoing phototherapy. Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or undergoing treatment for a photosensitive disease and is experiencing photosensitivity. Has had an adverse reaction in the past to medical laser procedures, such as laser hair removal or laser tattoo removal. Has had prior benign excisional breast biopsy on breast of interest within the past 18 months. Currently has mastitis. Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imagio<br>Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes | Device: Imagio<br>* Imagio - both ultrasound probe and Duplex OA probe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Imagio Image Sets Collected | Obtain ultrasound only probe images and OA/US (both gray scale and OA) probe images as measured by the receipt of image sets for each subject enrolled. | Baseline | 
| Number of Subjects With Completed Pathology Results | Provide breast pathology results per subject (except BI-RADS 1, 2 and 3 (as applicable)) if subject's study mass is biopsied | Baseline |