Fatty Liver Clinical Trial
Official title:
Improving the Performance of Ultrasound Shear Wave Elastography (SWE) in Obese Fatty Liver Disease Patients by Developing a Conditionally Increased Output (CIO) Enhanced Ultrasound System
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | December 15, 2024 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | GE Healthcare |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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 | Mean difference in IQR/Median ratio between standard and CIO SWE | IQR/median is a commonly accepted variability analysis tool for SWE. We are hoping to understand the variability difference between these two ultrasound modes in this safety study. | Single visit (1day) | |
Secondary | Mean difference in aspartate transaminase (AST) value in U/L unit between pre-imaging and day1 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 1 day after the ultrasound imaging (within 2 weeks timeframe) | |
Secondary | Mean difference in aspartate transaminase (AST) value in U/L unit between pre-imaging and day2 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 2 day after the ultrasound imaging (within 2 weeks timeframe) | |
Secondary | Mean difference in alanine transaminase (ALT) value in U/L unit between pre-imaging and day1 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 1 day after the ultrasound imaging (within 2 weeks timeframe) | |
Secondary | Mean difference in alanine transaminase (ALT) value in U/L unit between pre-imaging and day2 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 2 day after the ultrasound imaging (within 2 weeks timeframe) | |
Secondary | Mean difference in alkaline phosphatase (ALP) value in U/L unit between pre-imaging and day1 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 1 day after the ultrasound imaging (within 2 weeks timeframe) | |
Secondary | Mean difference in alkaline phosphatase (ALP) value in U/L unit between pre-imaging and day2 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 2 day after the ultrasound imaging (within 2 weeks timeframe) |
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