Conditionally Increased Output (CIO) Enhanced Ultrasound System

NCT05792423 | Completed Results FDA Device

• 1 other identifier: 2022P003180
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess possible bioeffects that may be caused by the use of shear wave elastography (SWE) with conditionally increased acoustic output pressure (CIO). Bioeffects will be monitored by of a series of liver function tests (LFTs) with results graded according to the NCI scale for drug hepatoxicity. LFTs will be collected prior to SWE imaging using CIO, as well up to 7 days post-imaging. Secondarily, this study aims to understand the degree to which SWE imaging results have improved with the use of COI.

Conditions

Nonalcoholic Fatty Liver; Nonalcoholic Steatohepatitis; Fatty Liver

Outcome Measures

Primary Outcomes (3)

• Mean Difference in Aspartate Transaminase (AST) Value in U/L Unit Between Pre-imaging and day7 Post-imaging

  AST value difference between pre and post imaging will be collected to monitor potential liver injury effect of the CIO enhanced liver stiffness measurement method in this safety study.

  Pre-ultrasound imaging and 7 day after the ultrasound imaging (within 2 weeks timeframe)

• Mean Difference in Alanine Transaminase (ALT) Value in U/L Unit Between Pre-imaging and day7 Post-imaging

  ALT value difference between pre and post imaging will be collected to monitor potential liver injury effect of the CIO enhanced liver stiffness measurement method in this safety study.

  Pre-ultrasound imaging and 7 day after the ultrasound imaging (within 2 weeks timeframe)

• Mean Difference in Alkaline Phosphatase (ALP) Value in U/L Unit Between Pre-imaging and day7 Post-imaging

  ALP value difference between pre and post imaging will be collected to monitor potential liver injury effect of the CIO enhanced liver stiffness measurement method in this safety study.

  Pre-ultrasound imaging and 7 day after the ultrasound imaging (within 2 weeks timeframe)

Secondary Outcomes (7)

• Mean Difference in IQR/Median Ratio Between Standard and CIO SWE

  Single visit (1day)

• Mean Difference in Aspartate Transaminase (AST) Value in U/L Unit Between Pre-imaging and day1 Post-imaging

  Pre-ultrasound imaging and 1 day after the ultrasound imaging (within 2 weeks timeframe)

• Mean Difference in Aspartate Transaminase (AST) Value in U/L Unit Between Pre-imaging and day2 Post-imaging

  Pre-ultrasound imaging and 2 day after the ultrasound imaging (within 2 weeks timeframe)

• Mean Difference in Alanine Transaminase (ALT) Value in U/L Unit Between Pre-imaging and day1 Post-imaging

  Pre-ultrasound imaging and 1 day after the ultrasound imaging (within 2 weeks timeframe)

• Mean Difference in Alanine Transaminase (ALT) Value in U/L Unit Between Pre-imaging and day2 Post-imaging

  Pre-ultrasound imaging and 2 day after the ultrasound imaging (within 2 weeks timeframe)

Study Arms (1)

24 healthy adult volunteers

EXPERIMENTAL

Device: GE ultrasound system with increased acoustic output settings

Interventions

GE ultrasound system with increased acoustic output settings DEVICE

We will perform liver stiffness measurements with standard settings and an increased acoustic output enhanced ultrasound system. Pre and post ultrasound LFTs will be collected to monitor unexpected liver tissue damage.

24 healthy adult volunteers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• BMI 18.5-39.9
• Able to undergo abdominal ultrasound
• Able to undergo repeated blood sampling
• Stable medication and supplement list and dosing for 30 days preceding enrollment
• Willing to participate

You may not qualify if:

• Excess alcohol consumption: \> 7 units/week (F) or \> 14 units/week (M)
• Current diagnosis of drug induced liver injury
• Prior liver transplantation recipient
• Receiving drug/placebo in treatment trial now or within 30 days
• Received systemic chemotherapy within past 30 days.
• Confirmed or suspected pregnancy
• Pacemaker, nerve stimulator, or other implanted electronic device
• Plans to alter medication or supplement list or dosage during the study period
• Active or recent (within 30 days) acute illness
• Recent ultrasound contrast administration
• Recent alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) greater than the laboratory upper limit of normal.
• Other factors that the PI considers likely to compromise study endpoints or subject safety

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• GE Healthcare: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Limitations and Caveats

Two participants withdrew after enrollment, but before ultrasound imaging was performed and were therefore not included in the analysis.

Results Point of Contact

• Title: Anthony Samir
• Organization: MGH

asamir@mgh.harvard.edu

6176432009

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Service Chief, Ultrasound, Department of Radiology

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: March 31, 2023
• Study Start: June 30, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: May 23, 2025
• Results First Posted: February 14, 2025

Record last verified: 2025-05

Locations

US (1)