Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373536
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-04-05
Brief Title:
Comparison of MRI-PDFF to TAEUS FLIP Device to Estimate Liver Fat Fraction in Adults
Sponsor:
Endra Lifesciences
Organization:
Endra Lifesciences
Study Overview
Official Title:
Comparison of Thermoacoustic Enhanced Ultrasound for Estimating Liver Fat Fraction to MRI-PDFF
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary nonalcoholic fatty Liver disease NAFLD is an excess of fat in the liver steatosis that is not a result of excessive alcohol consumption or other secondary causes11 NAFLD is defined by the presence of hepatic fat content steatosis in 5 of hepatocytes and is currently the most common liver disease worldwide14 Non-Alcoholic Fatty Liver Disease NAFLD is the world39s most common liver disease and affects around 33 of the adult population
Nonalcoholic steatohepatitis NASH a progressive form of nonalcoholic fatty liver disease NAFLD is a growing clinical concern associated with the increasing prevalence of obesity type 2 diabetes and metabolic syndrome NASH is characterized by the presence of hepatic steatosis inflammation and hepatocellular injury and is predicted to be the leading indication for liver transplantation by 20201 Patients with NASH have an increased risk of developing cirrhosis and its complications such as ascites variceal hemorrhage hepatic encephalopathy hepatocellular carcinoma and liver failure The prevalence worldwide of NAFLD in the general population is estimated at 20-352 Around 2-3 of the population have NASH
In patients with type 2 diabetes the prevalence is even over 50 555 globally 68 in Europe In Germany the NAFLD prevalence was 23 in 2016 and will be around 26 in 2030 The prevalence of non-alcoholic alcoholic steatohepatitis NASH ie the progressive form of NAFLD is estimated at 4 of the adult population in Germany and will increase to 6 by 2030 This means that NAFLD is already the most common chronic liver disease worldwide and one of the leading causes of liver-related complications cirrhosis decompensation hepatocellular carcinoma liver transplantation and deaths NAFLD and NASH are largely underdiagnosed worldwide
Nonalcoholic steatohepatitis NASH a progressive form of nonalcoholic fatty liver disease NAFLD is a growing clinical concern associated with the increasing prevalence of obesity type 2 diabetes and metabolic syndrome NASH is characterized by the presence of hepatic steatosis inflammation and hepatocellular injury and is predicted to be the leading indication for liver transplantation by 20201 Patients with NASH have an increased risk of developing cirrhosis and its complications such as ascites variceal hemorrhage hepatic encephalopathy hepatocellular carcinoma and liver failure The prevalence worldwide of NAFLD in the general population is estimated at 20-352 Around 2-3 of the population have NASH
In patients with type 2 diabetes the prevalence is even over 50 555 globally 68 in Europe In Germany the NAFLD prevalence was 23 in 2016 and will be around 26 in 2030 The prevalence of non-alcoholic alcoholic steatohepatitis NASH ie the progressive form of NAFLD is estimated at 4 of the adult population in Germany and will increase to 6 by 2030 This means that NAFLD is already the most common chronic liver disease worldwide and one of the leading causes of liver-related complications cirrhosis decompensation hepatocellular carcinoma liver transplantation and deaths NAFLD and NASH are largely underdiagnosed worldwide
Detailed Description:
Early detection and surveillance of steatosis hepatis improves the chances of management or even improvement of the disease before irreversible damage occurs12 Liver tissue biopsy is the current reference standard for the diagnosis and severity of steatosis hepatis However due to its invasiveness biopsy collection is not suitable for screening or regular follow-up The diagnostic techniques of magnetic resonance spectroscopy MRS and MRI-PDFF proton density fat fraction for the assessment of liver fat content have been shown to correlate well with the results of liver biopsy but are particularly associated with high costs low availability long examination times and exclusion of patients with metal implants Conventional B-scan ultrasonography is the most commonly used imaging modality for assessing steatosis hepatis based on qualitative image features of the liver These include an echo-enhanced internal reflex pattern of the liver parenchyma loss of signal in depth blurred demarcation of the blood vessels and diaphragm or areas of focal obesity The sensitivity and specificity of conventional sonography is high in severe steatosis hepatis On the other hand the sensitivity is significantly worse in mild cases In addition intra- and interobserver reliability are poor in the assessment of steatosis hepatis of the conventional B-scan
Quantitative ultrasound-based methods are the current standard of practice for point-of-care noninvasive liver fat assessment However due to low penetration depth and confounding factors invalid or poor-quality measurements are often encountered in large patients or patients with liver fibrosis In contrast to purely ultrasound-based approaches thermoacoustic TA approaches are sensitive to tissue composition chemistry rather than acoustic scattering andor attenuation making TA measurements of liver fat content relatively insensitive to liver fibrosis or patient size
Thermoacoustic imaging technology is non-invasive and combines short pulses of radio-frequency energy to create ultrasound signals acoustic waves in tissue to create images or measurements of fat in body tissues The radio-frequency energy that is used to create thermoacoustic ultrasound signals is very similar to that used by cell phones and MRI scanners Thermoacoustic signals are created in proportion to how well tissue is able to conduct electricity Lean tissues are highly conductive while fatty tissues are not and thus thermoacoustics is able to differentiate lean and fatty tissues A primary interest in detecting and monitoring metabolic health is measuring liver fat content Thermoacoustic approaches to fat measurement in the liver have several unique advantages compared to other currently used technologies including ultrasound and MRI Medical ultrasound scanners are widely available but often have difficulty making high-quality images and reliable measurements in larger patients or deeper tissues Thermoacoustic ultrasound signals are formed in the tissue allowing measurements of fat to be made at depths that may not be possible with conventional ultrasound systems While MRI is the most accurate noninvasive method to estimate fat in tissue it has limited availability and is very expensive compared to thermoacoustics and thus impractical for widespread use that is needed to address the growing problem of fatty liver disease and metabolic syndrome
Thermoacoustic approaches to fat measurement in tissue are exceptionally safe using radio frequency energy levels similar to MRI with tissue heating that is less than a 0001 degrees Celsius per pulse in temperature ENDRA has developed a noninvasive bedside device called the TAEUS-FLIP system for measuring fat in liver tissue The TAEUS-FLIP exam is performed during a routine exam and takes between 5-10 minutes to perform The TAEUS-FLIP system has the potential to bring wide access to accurate liver fat measurements to a wide range of patient populations and to address the unmet need for detecting and monitoring patients with fatty liver disease and metabolic syndrome
In this study the investigators want to compare TAEUS FLIP with MRI-PDFF to gain insight into the potential of thermoacoustic methods to assess liver fat content similar to MRI-PDFF Unlike conventional quantitative ultrasound methods the thermoacoustic approach has demonstrated the potential to obtain estimates of liver fat fraction in individuals with high BMI 45 and those with confirmed liver fibrosis
Quantitative ultrasound-based methods are the current standard of practice for point-of-care noninvasive liver fat assessment However due to low penetration depth and confounding factors invalid or poor-quality measurements are often encountered in large patients or patients with liver fibrosis In contrast to purely ultrasound-based approaches thermoacoustic TA approaches are sensitive to tissue composition chemistry rather than acoustic scattering andor attenuation making TA measurements of liver fat content relatively insensitive to liver fibrosis or patient size
Thermoacoustic imaging technology is non-invasive and combines short pulses of radio-frequency energy to create ultrasound signals acoustic waves in tissue to create images or measurements of fat in body tissues The radio-frequency energy that is used to create thermoacoustic ultrasound signals is very similar to that used by cell phones and MRI scanners Thermoacoustic signals are created in proportion to how well tissue is able to conduct electricity Lean tissues are highly conductive while fatty tissues are not and thus thermoacoustics is able to differentiate lean and fatty tissues A primary interest in detecting and monitoring metabolic health is measuring liver fat content Thermoacoustic approaches to fat measurement in the liver have several unique advantages compared to other currently used technologies including ultrasound and MRI Medical ultrasound scanners are widely available but often have difficulty making high-quality images and reliable measurements in larger patients or deeper tissues Thermoacoustic ultrasound signals are formed in the tissue allowing measurements of fat to be made at depths that may not be possible with conventional ultrasound systems While MRI is the most accurate noninvasive method to estimate fat in tissue it has limited availability and is very expensive compared to thermoacoustics and thus impractical for widespread use that is needed to address the growing problem of fatty liver disease and metabolic syndrome
Thermoacoustic approaches to fat measurement in tissue are exceptionally safe using radio frequency energy levels similar to MRI with tissue heating that is less than a 0001 degrees Celsius per pulse in temperature ENDRA has developed a noninvasive bedside device called the TAEUS-FLIP system for measuring fat in liver tissue The TAEUS-FLIP exam is performed during a routine exam and takes between 5-10 minutes to perform The TAEUS-FLIP system has the potential to bring wide access to accurate liver fat measurements to a wide range of patient populations and to address the unmet need for detecting and monitoring patients with fatty liver disease and metabolic syndrome
In this study the investigators want to compare TAEUS FLIP with MRI-PDFF to gain insight into the potential of thermoacoustic methods to assess liver fat content similar to MRI-PDFF Unlike conventional quantitative ultrasound methods the thermoacoustic approach has demonstrated the potential to obtain estimates of liver fat fraction in individuals with high BMI 45 and those with confirmed liver fibrosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None