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

Not Applicable

Completed

• Conditions: Breast Cancer Stage
• Interventions: Device: Imagio

• Registration Number: NCT05022602
• Lead Sponsor: Seno Medical Instruments Inc.

Brief Summary

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

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 Timeline

• Study Start: 2021-08-19
• Study First Submitted: 2021-08-20
• Study First Submitted QC: 2021-08-20
• Study First Posted: 2021-08-26
• Primary Completion: 2022-02-17
• Study Completion: 2022-02-17
• Results First Submitted: 2023-01-19
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-28
• Last Update Submitted: 2023-03-28
• Results First Posted: 2023-03-29
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imagio	Imagio	Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Completed Pathology Results	Baseline	Provide breast pathology results per subject (except BI-RADS 1, 2 and 3 (as applicable)) if subject's study mass is biopsied
Number of Participants With Imagio Image Sets Collected	Baseline	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.

Trial Locations

Locations (1)

UT Health; 🇺🇸 San Antonio, Texas, United States