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

Not Applicable

Suspended

• Conditions: Breast Cancer
• Interventions: Device: Gen 1B; Device: Gen 1

• Registration Number: NCT03845907
• Lead Sponsor: Seno Medical Instruments Inc.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-11-07
• Study Start: 2018-12-19
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-19
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-06
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Imagio Gen 1	Gen 1B	Gen 1 duplex probe ultrasound / optoacoustic imaging of the breast and axillary lymph node, with the IMAGIO System
Imagio Gen 1	Gen 1	Gen 1 duplex probe ultrasound / optoacoustic imaging of the breast and axillary lymph node, with the IMAGIO System
Imagio Gen 1B	Gen 1	Gen 1B duplex probe ultrasound / optoacoustic imaging of the breast and axillary lymph node, with the IMAGIO System and the Gen1B duplex probe
Imagio Gen 1B	Gen 1B	Gen 1B duplex probe ultrasound / optoacoustic imaging of the breast and axillary lymph node, with the IMAGIO System and the Gen1B duplex probe

Primary Outcome Measures

Name	Time	Method
Number of Subjects with Treatment-related Events	At end of study, average of six months	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
Diagnostic Image Quality of Gen 1B	At end of study, average of six months	Independent reader comparison using questionnaire and measurements on artifacts and features of Gen 1 Gen1B probe images for pair wise comparison

Secondary Outcome Measures

Name	Time	Method
Probe performance data comparison across skin types	At end of study, average of six months	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.
Image Quality between probes at reduced laser level	At end of study, average of six months	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

Trial Locations

Locations (1)

Seno Medical; 🇺🇸 San Antonio, Texas, United States