Loading clinical trials...

COMPLETEDNA

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

NCT05022602•Seno Medical Instruments Inc.

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))

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

UT Health

San Antonio, Texas, United States

Key Dates

Start Date

August 19, 2021

Primary Completion Date

February 17, 2022

Completion Date

February 17, 2022

Last Updated

March 29, 2023

Enrollment

ACTUAL participants

Conditions

Breast Cancer Stage

Interventions

Imagio

DEVICE

Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

NCT06806930

Breast Cancer Stage IBreast Cancer Stage II+2 more

View study

RECRUITINGPHASE2

Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer

NCT07188246

Breast CancerBreast Cancer Stage II+3 more

View study

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: March 29, 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.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer

A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.

Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer

Medical Imaging and Thermal Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)

Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer