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

Seno Medical

Status: Completed

Conditions: Breast Cancer Stage

Treatments: Device: Imagio

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05022602

Gen 2 - 01

Details and patient eligibility

About

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).

Full 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))

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Imagio

Experimental group

Description:

Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes

Treatment:

Device: Imagio