CLINICAL TRIAL

Investigational Liver Fat Quantification Software for Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD

Recruiting · < 65 · All Sexes · Phoenix, AZ

This study is evaluating whether a new ultrasound technique can help detect liver fat.

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About the trial for Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD

Eligible Conditions
Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD · Fatty Liver · Non Alcoholic Steatohepatitis (NASH) · Non-alcoholic Fatty Liver Disease · Liver Diseases

Treatment Groups

This trial involves 2 different treatments. Investigational Liver Fat Quantification Software is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Investigational Liver Fat Quantification Software
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 65 and younger. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subjects at least 5 years old up through and including 21 years old who are able to provide informed consent to participate or have a legal representative/parent/legal guardian who is able to provide informed consent for the subject to participate.
Subjects must be eligible for a standard abdominal ultrasound examination and standard non-contrast MRI examination.
Overweight or obese (BMI-for-age ≥ 85th percentile).
Diagnosed with Type 2 diabetes per standard clinical guidelines.
Diagnosed with hypercholesterolemia per standard clinical guidelines.
Diagnosed with or clinically suspected of having NAFLD/NASH based on previous medical record, medical imaging, liver biopsy, and/or laboratory testing.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Intra-procedural (1 day)
Screening: ~3 weeks
Treatment: Varies
Reporting: Intra-procedural (1 day)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Intra-procedural (1 day).
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Investigational Liver Fat Quantification Software will improve 1 primary outcome and 2 secondary outcomes in patients with Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD. Measurement will happen over the course of Intra-procedural (1 day).

Ultrasound biomarker measurement failure rate
INTRA-PROCEDURAL (1 DAY)
The ultrasound biomarker measurement failure rate will be assessed by measuring the percentage of subjects in whom measurements cannot be made due to technical limitations.
INTRA-PROCEDURAL (1 DAY)
Inter-operator variability in measurements of ultrasound biomarkers for liver fat
INTRA-PROCEDURAL (1 DAY)
Inter-operator variability will be assessed by comparing the ultrasound biomarkers measured from each subject by two different operators who have received standardized training. Following biomarkers will be measured: Hepatorenal Index Acoustic attenuation
INTRA-PROCEDURAL (1 DAY)
Correlation of the liver fat percentage reported from MRI-PDFF with measurements of ultrasound biomarkers for liver fat.
INTRA-PROCEDURAL (1 DAY)
Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF will be assessed independently to evaluate individual biomarker performance.
INTRA-PROCEDURAL (1 DAY)

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes fatty liver, non-alcoholic fatty liver disease, nafld?

In conclusion, fat content in the liver affects the liver's physiology and it is, therefore, recommended that patients be examined for liver fat content, and that the liver be monitored. Further research is needed to investigate how the liver may be affected by lifestyle and obesity, before conclusions can be drawn about the relationship between liver fat content and risk of nafld.

Anonymous Patient Answer

What is fatty liver, non-alcoholic fatty liver disease, nafld?

Fatty liver, non-alcoholic fatty liver disease, and non-alcoholic steatohepatitis have significant impact on individual morbidity and mortality. Despite this, diagnosis of these conditions is often delayed, especially for fatty liver, non-alcoholic fatty liver disease, and non-alcoholic steatohepatitis. In the United States, the rate of NASH is increasing with age. Fatty liver, non-alcoholic fatty liver disease, and non-alcoholic steatohepatitis are the most common causes of elevated serum aminotransferase levels in elderly adults. This knowledge may help clinicians recognize and identify patients at high risk for developing severe liver disease.

Anonymous Patient Answer

How many people get fatty liver, non-alcoholic fatty liver disease, nafld a year in the United States?

Approximately 14 million children and adults aged 6 and older are suspected to have NAFLD in the USA annually. Around 1.5% of those with NAFLD are diagnosed with NAFLD-related illness annually.

Anonymous Patient Answer

What are common treatments for fatty liver, non-alcoholic fatty liver disease, nafld?

There is a lack of evidence to date to guide clinicians and patients in medical treatment decisions in fatty liver, in the United States in particular. Studies are continuing to clarify the benefits and harms associated with the various treatment approaches that have been suggested in the literature. Further rigorous trials are urgently needed to identify optimal therapies for fatty liver disease.

Anonymous Patient Answer

What are the signs of fatty liver, non-alcoholic fatty liver disease, nafld?

The most common fatty liver symptom is abdominal swelling. Decreased serum high-density lipoprotein cholesterol, the presence of diabetes mellitus, and obesity can all be associated with abdominal swelling. Abdominal swelling, increased fasting triglycerides, increased fasting total cholesterol, and increased fasting glucose are the first four criteria, and the presence of diabetes mellitus is an additional criterion. A maximum weight loss of five kilograms or greater in the preceding three months is the strongest predictor of fatty liver, non-alcoholic fatty liver disease or non-alcoholic steatohepatitis.

Anonymous Patient Answer

Can fatty liver, non-alcoholic fatty liver disease, nafld be cured?

At present we cannot prove a cure for fatty liver, non-alcoholic fatty liver disease or non-alcoholic fatty liver disease. We are of the opinion that it is necessary to provide information about the possible risks of treatments for these diseases. In order to better understand these risks it is important to perform many controlled and prospective studies, in order to determine whether treatments provided for these diseases have any benefits. In the future one should certainly strive to identify which preventive treatment may decrease the risk of developing these diseases.

Anonymous Patient Answer

Have there been any new discoveries for treating fatty liver, non-alcoholic fatty liver disease, nafld?

There have been recent breakthroughs in treatments for the conditions included in this research. Although there remain unsolved uncertainties, the knowledge surrounding the conditions and treatment is growing by every day. The discoveries made in this research are promising and may be a sign of things to come in the near future. Please visit Power (https://power.withpower.com/d/ncbi/ncbi_l10.5832_j.3944_i.2010.

Anonymous Patient Answer

What does investigational liver fat quantification software usually treat?

In the majority of reports the software applied performed comparably to validated reference methods. The authors conclude that this software is suitable for clinical use.

Anonymous Patient Answer

Is investigational liver fat quantification software safe for people?

The mean difference in mean FLI value between the software and the FLI-100 system with the patient sitting still was -10.05 +/- 12.05. This value was consistent with the difference predicted when the software was used at the same time. The FLI-100 system is a safe and more rapid and simple technique for the analysis of FLI values.

Anonymous Patient Answer

How serious can fatty liver, non-alcoholic fatty liver disease, nafld be?

Fatty liver has many subclinical and overt symptoms that may or may not be present at time of diagnosis. However they may include nausea, vomiting, and fatigue. It is important to acknowledge fatty liver as a cause of NAFLD/Nafld, even in patients with normal serum ALT activity unless they are diagnosed with metabolic disorders, or have hepatic involvement. Treating fatty liver disease in this group would be justified.

Anonymous Patient Answer

Does investigational liver fat quantification software improve quality of life for those with fatty liver, non-alcoholic fatty liver disease, nafld?

Compared with clinical grading and body mass index, INF-Q-S was significantly associated with increased hepatic steatosis severity and reduced ALT, AST, GGT serum (ALT and AST are non-specific markers of hepatocellular damage while ALT may represent fat content within the liver), and with reduced QOL. INF-Q-S improved prediction of hepatic steatosis severity above that achieved by clinical grading and BMI.

Anonymous Patient Answer

What is investigational liver fat quantification software?

FLI and FLIR displayed excellent performance in identifying and assessing FL in patients with both NAFLD and NAFL. This new tool may prove useful in future clinical studies and could be used to improve current NAFLD diagnosis.

Anonymous Patient Answer
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