Evaluating a new device for assessing fatty liver disease
Feasibility Study for Quantifying Fatty Liver Using Thermo-acoustic Imaging
This study is testing a new ultrasound device to see if it can accurately measure fat in the liver for people with non-alcoholic fatty liver disease compared to MRI scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT04302051 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the accuracy of a thermo-acoustic ultrasound device in estimating hepatic steatosis compared to MRI-PDFF in patients with non-alcoholic fatty liver disease. Participants will undergo imaging procedures using both modalities, and the results from the thermo-acoustic ultrasound will be compared to those from MRI to determine its diagnostic sensitivity. The study focuses on patients aged 18-70 who have a known or suspected diagnosis of fatty liver disease. The goal is to establish the effectiveness of this new imaging technique in diagnosing hepatic steatosis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a diagnosis or suspicion of non-alcoholic fatty liver disease.
Not a fit: Patients with metal or electronic implants, or those who are pregnant or unable to undergo imaging examinations will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate and accessible method for diagnosing fatty liver disease.
How similar studies have performed: Other studies have explored imaging techniques for fatty liver disease, but the specific use of thermo-acoustic ultrasound in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients diagnosed or suspected to have non-alcoholic fatty liver disease * Patients 18-70 years of age * be able to understand and sign on written informed consent * able to undergo ultrasound and MRI examinations Exclusion Criteria: * any metal or electronic implants including but not limited to pacemakers, clips, hips * known history of pregnancy or becoming pregnant during study period * unable to understand and sign on written informed consent * intolerant to ultrasound and/or MRI examinations
Where this trial is running
Milwaukee, Wisconsin
- Froedtert Hospital — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Achuthan Sourianarayanane, Md — Medical College of Wisconsin
- Study coordinator: Achuthan Md Sourianarayanane, Md
- Email: asourianar@mcw.edu
- Phone: 4149556850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.