Ultrasound Biomarker for Fatty Liver Disease
(LYNX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to measure liver fat using ultrasound, a simple imaging tool. The goal is to find an easier way to detect early signs of a common liver condition linked to obesity, diabetes, high blood pressure, or high cholesterol. Current tests can be costly or involve needles, so this method could offer a more accessible option. Suitable participants include healthy adults or those with, or suspected to have, fatty liver disease, or those meeting criteria such as having diabetes or obesity. As an unphased trial, this study allows participants to contribute to innovative research that could simplify liver health assessments.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that this ultrasound biomarker is safe for measuring liver fat?
Studies have shown that ultrasound is often used to check for fatty liver disease. This common method has been safely used in medical settings for a long time. Research indicates that ultrasound measures liver fat non-invasively, without surgery or needles. No reports of serious side effects have emerged from using ultrasound in this way.
Ultrasound provides a safe and painless way to examine the body. It doesn't use radiation, making it safer than methods like X-rays or CT scans. Since ultrasound already helps detect fatty liver disease, this new tool, a measurable ultrasound marker, is expected to be well-tolerated.
In summary, using ultrasound for this purpose is safe. People considering joining this study can feel confident about the safety of the ultrasound method.12345Why are researchers excited about this trial?
Researchers are excited about developing a quantifiable ultrasound biomarker for fatty liver disease because it offers a non-invasive way to assess liver health. Unlike current methods, such as liver biopsy, which can be painful and carry risks, this ultrasound technique could provide a safer, quicker, and more comfortable experience for patients. Additionally, the ability to quantify liver fat with a simple ultrasound could allow for more accurate monitoring of disease progression and response to treatment, potentially leading to earlier interventions and better patient outcomes.
What evidence suggests that this ultrasound biomarker is effective for detecting fatty liver disease?
Research has shown that ultrasound is a useful tool for checking liver fat levels. Studies have found that ultrasound can determine the amount of fat in the liver by analyzing the sound waves it produces. This trial will focus on developing a quantifiable ultrasound biomarker for fatty liver disease. Ultrasound could serve as a helpful, non-invasive way to monitor liver health, especially for individuals at risk of liver issues related to metabolic problems. Unlike more costly and invasive tests like MRI or liver biopsy, ultrasound offers a simpler and more accessible method to track liver fat. Early use of this approach could aid in managing health conditions linked to obesity, diabetes, and high cholesterol.25678
Are You a Good Fit for This Trial?
This trial is for individuals with conditions related to excess liver fat, such as Nonalcoholic Steatohepatitis and various forms of Fatty Liver Disease. The study aims to include those who may benefit from a non-invasive diagnostic tool due to the risks or limitations associated with current methods like MRI or biopsy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Data Collection
Collection of raw radiofrequency data and other clinical and radiological datasets from healthy volunteers and subjects with MASLD
Follow-up
Participants are monitored for safety and effectiveness after data collection
What Are the Treatments Tested in This Trial?
Interventions
- Development of a Quantifiable Ultrasound Biomarker
Trial Overview
The study is testing new ultrasound technologies (Philips 3T Ingenia Elition, Verasonics NXT Data Acquisition System, Philips EPIQ Elite, EchoSense FibroScan) to measure liver fat percentage non-invasively. This could lead to an easier way for doctors to monitor liver health in patients at risk of MASLD.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Adult healthy volunteers as well as subjects who have a diagnosis, or suspected, of having MASLD or are deemed to meet the high-risk cardiometabolic criteria.
Find a Clinic Near You
Who Is Running the Clinical Trial?
ContextVision AB
Lead Sponsor
University of Washington
Collaborator
Citations
Metabolic and hepatic biomarkers associated with MASLD in ...
Fatty liver disease is characterized by the excessive accumulation of fat in liver cells due to various causes and is primarily classified into ...
Longitudinal Outcomes Associated With Metabolic ...
In studies where hepatic steatosis was assessed with ultrasound, the degree of steatosis was further stratified to mild (diffuse increase in fine echoes in ...
3.
diabetesjournals.org
diabetesjournals.org/care/article/48/7/1057/160536/Metabolic-Dysfunction-Associated-Steatotic-LiverMetabolic Dysfunction–Associated Steatotic Liver Disease ...
Metabolic dysfunction–associated steatotic liver disease (MASLD) in people with diabetes: The need for screening and early intervention.
Imaging Biomarkers in Metabolic Dysfunction Associated ...
Liver Fibrosis, but No Other Histologic Features, Is Associated With Long-term Outcomes of Patients With Nonalcoholic Fatty Liver Disease.
Machine learning models using non-invasive tests & B ...
Machine learning models using non-invasive tests & B-mode ultrasound to predict liver-related outcomes in metabolic dysfunction-associated ...
Metabolic Dysfunction-Associated Steatotic Liver Disease ...
... ultrasonography is commonly used to screen for fatty liver disease. The prevalence of MASLD is 80% to 90% in obese adults, 30% to 50% in ...
Metabolic dysfunction-associated steatotic liver disease
In 10–20% of individuals, hepatic steatosis can be complicated by a state of inflammation, lipotoxicity and apoptosis known as metabolic dysfunction-associated ...
Pathophysiology, noninvasive diagnostics and emerging ...
... Associated Steatotic Liver Disease (MASLD), is a leading cause of chronic liver disease, driving cirrhosis, liver cancer, and mortality.
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