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COMPLETEDNANCT05022602

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).

Lead sponsor: Seno Medical Instruments Inc.•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Seno Medical Instruments Inc.

Collaborators

American College of Radiology

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))

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 29, 2023Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment38

Start dateAug 2021

Last updatedMar 29, 2023

Condition

Breast Cancer Stage

Locations shown

UT Health

San Antonio, Texas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 29, 2023Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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