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

Breast Cancer Stage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05022602
• Other study ID #: Gen 2 - 01
• Status: Completed
• Phase: N/A
• Start date: August 19, 2021
• Est. completion date: February 17, 2022

Study information

• Verified date: March 2023
• Source: Seno Medical Instruments Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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))

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 17, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Stage

Intervention

Device:
• Imagio
Imagio - both ultrasound probe and Duplex OA probe

Locations

Country	Name	City	State
United States	UT Health	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Seno Medical Instruments Inc.	American College of Radiology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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