Ignite Creation Date:
2024-05-06 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05189990
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2021-12-17
Brief Title:
Electrical Impedance Tomography in Fatty Liver Detection
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Investigation of the Electrical Impedance Tomography EIT Effectiveness in Detecting Fatty Liver Disease
Status:
COMPLETED
Status Verified Date:
2024-05
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:
Non-alcoholic fatty liver disease NAFLD is a condition where hepatocytes contain an abnormally high fat percentage This condition is becoming increasingly common due to unhealthy food habits and sedentary lifestyle Since NAFLD is a silent disease many patients would be diagnosed at the advanced stages when fat accumulation scarring and liver cell damage are irreversible Therefore early diagnosis of fatty liver disease during its reversible stages is warranted Current diagnostic techniques for fatty liver disease such as the FibroScan and MRI proton density fat fraction PDFF are expensive and require the active work of certified professionals Electrical Impedance Tomography EIT is an alternative low cost non-invasive imaging technique that does not involve radiation nor a trained operator The electrical conductivity of biological tissues varies according to the tissue type and frequency of AC current Fat tissue conductivity is known to be substantially stable across the EIT current injection frequency spectrum On the other hand liver tissue conductivity significantly increases over frequency change Hence the liver fat content can be measured using frequency-difference EIT fdEIT The aim of this study is to investigate the feasibility and effectiveness of fdEIT in detecting fatty liver To achieve this goal a total of 160 subjects will be recruited paired fdEIT-Fibroscan data will be acquired First optimal fdEIT current injection frequency range will be determined Second fdEIT derived indicators will be computed and statistical analysis will be performed to verify the significance of correlation between the two Comparative exploration between EIT and MRI-PDFF will be performed on a subset of the study population looking at both spatial localization and image derived indicators
Finally demographics clinical assessment and patient history will be analysed to produce demographic group-based insights
Finally demographics clinical assessment and patient history will be analysed to produce demographic group-based insights
Detailed Description:
Fatty liver disease is a condition where the hepatocytes liver cells contain more than 5 fat This condition is becoming increasingly common due to unhealthy food habits and sedentary lifestyle Since NAFLD is a silent disease with symptoms arising only at the later stages eg fibrosis many patients would be diagnosed at the advanced stages when fat accumulation scarring and liver cell damage are irreversible Therefore early diagnosis of silent fatty liver disease during its reversible stages is important to prevent cell damage liver transplantation and allow better long-term prognosis
Currently liver biopsy is the gold standard in diagnosis and prognosis of fatty liver disease However biopsies are invasive expensive and involve risks of internal bleeding and high sampling error Non-invasive diagnostic tests include blood tests FibroScan and MRI FibroScan Echosens Paris France is a quick 10 minutes non-invasive test which measures the fatty change Normal liver fat amount has controlled attenuation parameter CAP 248 dBm which is S0 while mild fatty liver has CAP 248-267 dBm or S1 Moderate fatty liver has CAP 268-279 dBm or S2 and lastly severe fatty liver has CAP 279 dBm or S3 Karlas et al 2017 The device is known to have reduced reliability for patients who are morbidly obese or have ascites It also heavily relies on the operator experience Another liver fat quantification method is MRI-based proton density fat fraction MRI-PDFF MRI-PDFF is a noninvasive imaging tool which can accurately and precisely calculate the percentage of liver fat over the whole liver Nevertheless MRI-PDFF takes a long time 30 minutes is expensive not portable and not routinely accessible
EIT could be an alternative low cost noninvasive imaging technique that does not involve radiation and is routinely accessible Existing EIT commercial devices are at present being deployed in some clinical settings EIT technology has been in use since more than a decade although so far it has mostly been used to assist mechanically ventilated patients in intensive care units to prevent lung damage caused by artificial ventilation
Within the past few years non-clinical research studies on applying EIT for fatty liver detection in animal and human models have been performed The electrical conductivity of biological tissues varies according to the tissue type and frequency of AC current On one hand fat tissue conductivity is known to be substantially stable across the EIT current injection frequency spectrum On the other hand liver tissue conductivity significantly increases over frequency change Hence biological tissues can potentially be differentiated using EIT frequency spectrum analysis
Currently liver biopsy is the gold standard in diagnosis and prognosis of fatty liver disease However biopsies are invasive expensive and involve risks of internal bleeding and high sampling error Non-invasive diagnostic tests include blood tests FibroScan and MRI FibroScan Echosens Paris France is a quick 10 minutes non-invasive test which measures the fatty change Normal liver fat amount has controlled attenuation parameter CAP 248 dBm which is S0 while mild fatty liver has CAP 248-267 dBm or S1 Moderate fatty liver has CAP 268-279 dBm or S2 and lastly severe fatty liver has CAP 279 dBm or S3 Karlas et al 2017 The device is known to have reduced reliability for patients who are morbidly obese or have ascites It also heavily relies on the operator experience Another liver fat quantification method is MRI-based proton density fat fraction MRI-PDFF MRI-PDFF is a noninvasive imaging tool which can accurately and precisely calculate the percentage of liver fat over the whole liver Nevertheless MRI-PDFF takes a long time 30 minutes is expensive not portable and not routinely accessible
EIT could be an alternative low cost noninvasive imaging technique that does not involve radiation and is routinely accessible Existing EIT commercial devices are at present being deployed in some clinical settings EIT technology has been in use since more than a decade although so far it has mostly been used to assist mechanically ventilated patients in intensive care units to prevent lung damage caused by artificial ventilation
Within the past few years non-clinical research studies on applying EIT for fatty liver detection in animal and human models have been performed The electrical conductivity of biological tissues varies according to the tissue type and frequency of AC current On one hand fat tissue conductivity is known to be substantially stable across the EIT current injection frequency spectrum On the other hand liver tissue conductivity significantly increases over frequency change Hence biological tissues can potentially be differentiated using EIT frequency spectrum analysis
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