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NCT05189990Completed

Electrical Impedance Tomography in Fatty Liver Detection

Investigation of the Electrical Impedance Tomography (EIT) Effectiveness in Detecting Fatty Liver Disease

Source: ClinicalTrials.gov · Last updated 8 May 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
160 (actual)
First submitted
17 Dec 2021
Start date
1 Jan 2022
Primary completion date
29 Feb 2024
Lead sponsor
The University of Hong Kong
NCT number
NCT05189990

What you commit to

  • Study type: Observational
  • Participants enrolled: 160
  • From 1 Jan 2022 to the primary completion date, 29 Feb 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 who had any recent abdominal surgery
  • Metallic implants

Other illness

  • Subjects with spinal diseases/discomfort

Other

  • Subjects with damaged skin on the abdomen.
  • Subjects with implanted electronic devices.
  • Pregnant women
  • Ascites
  • Heavy alcohol intake

Who the study is looking for

  • 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.

Age in the registry: 20 years to 75 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The University of Hong Kong
Coordinator of this site? Confirm its status
Hong KongChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.