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

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).

Study Overview

• Status: Completed
• Conditions: Breast Cancer Stage
• Intervention / Treatment: Device: Imagio

Detailed Description

1. 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.
2. Provide breast and lymph node pathology results (except BI-RADS 1, 2 and 3 (as applicable))

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • UT Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Has a signed and dated informed consent, prior to initiation of any study-related activities.
2. Is at least 18 years of age.
3. Have been referred for a breast US because of a breast lesion/mass finding via a palpable lump or per standard of care imaging.
4. Is willing and able to comply with protocol-required scans

Exclusion Criteria:

1. Is pregnant or lactating.
2. 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.
3. 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.
4. Is currently undergoing phototherapy.
5. Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or undergoing treatment for a photosensitive disease and is experiencing photosensitivity.
6. Has had an adverse reaction in the past to medical laser procedures, such as laser hair removal or laser tattoo removal.
7. Has had prior benign excisional breast biopsy on breast of interest within the past 18 months.
8. Currently has mastitis.
9. Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imagio; Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes	Device: Imagio; Imagio - both ultrasound probe and Duplex OA probe

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seno Medical Instruments Inc.
• Collaborators: American College of Radiology
• Investigators: Principal Investigator: Pam Otto, MD, UTHSC

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2021
• Primary Completion (Actual): February 17, 2022
• Study Completion (Actual): February 17, 2022

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Gen 2 - 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.: No