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

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

Study Overview

• Status: Suspended
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Gen 1B; Device: Gen 1

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78230
      • Seno Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seno Medical Instruments Inc.
• Investigators: Study Director: A. Thomas Stavros, MD, Seno Medical

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2018
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: November 7, 2018
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 2, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: GEN1B-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes