N/A
N=24
Conditionally Increased Output (CIO) Enhanced Ultrasound System
Nonalcoholic Fatty Liver · Nonalcoholic Steatohepatitis · Fatty Liver
Bottom Line
View on ClinicalTrials.gov: NCT05792423 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Mean Difference in Aspartate Transaminase (AST) Value in U/L Unit Between Pre-imaging and day7 Post-imaging — -0.5 international units per liter
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GE ultrasound system with increased acoustic output settings (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Difference in Aspartate Transaminase (AST) Value in U/L Unit Between Pre-imaging and day7 Post-imaging |
-0.5 | — |
| PRIMARY Mean Difference in Alanine Transaminase (ALT) Value in U/L Unit Between Pre-imaging and day7 Post-imaging |
-0.3 | — |
| PRIMARY Mean Difference in Alkaline Phosphatase (ALP) Value in U/L Unit Between Pre-imaging and day7 Post-imaging |
2.2 | — |
| SECONDARY Mean Difference in IQR/Median Ratio Between Standard and CIO SWE |
-0.019 | — |
| SECONDARY Mean Difference in Aspartate Transaminase (AST) Value in U/L Unit Between Pre-imaging and day1 Post-imaging |
-0.9 | — |
| SECONDARY Mean Difference in Aspartate Transaminase (AST) Value in U/L Unit Between Pre-imaging and day2 Post-imaging |
-1.0 | — |
| SECONDARY Mean Difference in Alanine Transaminase (ALT) Value in U/L Unit Between Pre-imaging and day1 Post-imaging |
0.3 | — |
| SECONDARY Mean Difference in Alanine Transaminase (ALT) Value in U/L Unit Between Pre-imaging and day2 Post-imaging |
-0.6 | — |
| SECONDARY Mean Difference in Alkaline Phosphatase (ALP) Value in U/L Unit Between Pre-imaging and day1 Post-imaging |
1.7 | — |
| SECONDARY Mean Difference in Alkaline Phosphatase (ALP) Value in U/L Unit Between Pre-imaging and day2 Post-imaging |
1.3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05792423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.