Electrical Impedance Tomography in Fatty Liver Detection

NCT05189990 | Completed

• 1 other identifier: HKU-DM-MAK-NAFLD01
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

electrical impedance; controlled attenuation parameter; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Optimal electrical impedance tomography (EIT) injection frequencies for fatty liver detection

  The optimal EIT current injection frequencies used in the novel EIT-liver device for fatty liver assessment will be determined by gross data collection and fine-tuning, to shorten the EIT scan time

  24 months

Secondary Outcomes (1)

• The performance characteristics of EIT liver device in hepatic steatosis assessment compared to transient elastography

  24 months

Interventions

Electrical impedance tomography DIAGNOSTIC_TEST

Fatty liver patients will be recruited from the Department of Medicine at Queen Mary Hospital. Gender- and age- matched control subjects will be publicly recruited. Subjects will undergo the EIT-liver scan and FibroScan®. Selected subgroups will also undergo MRI-PDFF scan. The performance characteristics of the device and with respect to Fibroscan/ MRI-PDFF for liver fat quantification will be assessed.

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two populations will be included in this study: 1. Fatty liver patients: patients diagnosed with fatty liver disease at different stages of the disease according to hepatic steatosis grade (S1-S3). These patients will be recruited from the affiliated institution of the study team. 2. Controls: healthy subjects.

You may qualify if:

• Fatty liver patients diagnosed with fatty liver at S1, S2 and S3 stages, will be included.
• Control subjects will also be included (who do not have any known liver diseases). Healthy subjects will be chosen to be age and gender matched with case subjects.

You may not qualify if:

• Subjects with previous liver diseases (in the control group) or any liver diseases other than fatty liver (in fatty liver patients).
• Subjects who had any kind of liver surgery or liver transplantation.
• Subjects with damaged skin on the abdomen.
• Subjects with implanted electronic devices.
• Subjects with spinal diseases/discomfort
• Subjects who had any recent abdominal surgery
• Pregnant women
• Ascites
• Heavy alcohol intake
• Metallic implants

Sponsors & Collaborators

• The University of Hong Kong: lead
• Gense Technologies Ltd.: collaborator
• Innovation and Technology Commission, Hong Kong: collaborator

Study Sites (1)

The University of Hong Kong

Hong Kong, Select A State Or Province, 0000, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Lung-Yi Mak, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 13, 2022
• Study Start: January 1, 2022
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

CN (1)