Clinical Evaluation of Opto-Acoustic Image Quality With the Gen1B Duplex Probe in Breast Applications

Study Overview
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Brief Summary
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Comparative Evaluation of Gen1B (OA-16-1S) duplex OA/US probe versus Gen1 (OA-16-1) duplex OA/US probe in Healthy Subjects

Detailed Description
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This study performs the first clinical evaluation of the Gen1B (OA-16-1S) duplex OA/US probe. This probe includes design changes to improve reliability and performance compared to the Gen1 (OA-16-1) duplex OA/US probe. The performance of the Gen1 duplex probe is functionally equivalent to the PIONEER duplex probe (OA-15-3), which was used in previous clinical studies for suspicious breast masses.

Official Title
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Clinical Evaluation of Opto-Acoustic Image Quality With the Gen1B Duplex Probe in Breast Applications

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Gen 1B
* Device: Gen 1


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. Is willing to undergo an Imagio imaging evaluation and standard Ultrasound Evaluation of the breast and axillary lymph nodes. Is willing and able to comply with protocol-required scans. Exclusion Criteria: Is pregnant or lactating. Has a condition or impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, breast implants within the previous 12 months, etc.) where the duplex probe will come in contact with the subject, 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 sulfa, 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 a history of contact dermatitis induced by gold or chrome metal contact with skin. Has an acute or chronic hematoma and/or acute ecchymosis of the breast. Has had prior benign excisional breast biopsy within the past 18 months. Has nipple rings that cannot be removed or are not removed during Imagio evaluation. Currently has mastitis. Has focal pain in the breast.

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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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Unblinded feasibility study in healthy subjects
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Imagio Gen 1B<br>Gen 1B duplex probe ultrasound / optoacoustic imaging of the breast and axillary lymph node, with the IMAGIO System and the Gen1B duplex probe | Device: Gen 1B<br>* Diagnostic Ultrasound and Optoacoustic Imaging<br>Device: Gen 1<br>* Diagnostic Ultrasound and Optoacoustic Imaging<br>|
| Active Comparator: Imagio Gen 1<br>Gen 1 duplex probe ultrasound / optoacoustic imaging of the breast and axillary lymph node, with the IMAGIO System | Device: Gen 1B<br>* Diagnostic Ultrasound and Optoacoustic Imaging<br>Device: Gen 1<br>* Diagnostic Ultrasound and Optoacoustic Imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects with Treatment-related Events | Safety of the Gen 1B duplex Optoacoustic (OA)/ Ultrasound (US) probe in breast applications as compared to Gen 1 with respect to treatment-related events | At end of study, average of six months | 
| Diagnostic Image Quality of Gen 1B | Independent reader comparison using questionnaire and measurements on artifacts and features of Gen 1 Gen1B probe images for pair wise comparison | At end of study, average of six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probe performance data comparison across skin types | The effect of skin pigmentation using the Fitzpatrick Scale (skin typing test), from Type I (always burns, never tans (palest; freckles) to Type VI never burns (deeply pigmented dark brown to darkest brown) will be used to determine similarities and differences between probes. | At end of study, average of six months | 
| Image Quality between probes at reduced laser level | OA images with reduced laser level energy will be collected to determine via a 7 point image quality scale, where 1 is poor and 7 is best, which probe produces better images by independent readers | At end of study, average of six months |