Non-Alcoholic Fatty Liver DiseaseNCT05189990
Electrical Impedance Tomography in Fatty Liver Detection
An observational study of Non-Alcoholic Fatty Liver Disease, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Electrical impedance tomography
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Pregnant women
- Ascites
- Heavy alcohol intake
- Metallic implants
Trial locations and contacts
1 site in 1 country.
China1 site
The University of Hong Kong
Hong Kong, Select A State Or Province, 0000
About this study
Official title: Investigation of the Electrical Impedance Tomography (EIT) Effectiveness in Detecting Fatty Liver Disease
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.
Read the 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 (e.g., 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 dB/m which is S0, while mild fatty liver has CAP 248-267 dB/m or S1. Moderate fatty liver has CAP 268-279 dB/m or S2 and lastly severe fatty liver has CAP >279 dB/m 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Electrical impedance tomography
- Keywords
- electrical impedance, controlled attenuation parameter, magnetic resonance imaging
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical impedance tomographyDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (1)
The performance characteristics of EIT liver device in hepatic steatosis assessment compared to transient elastography
The correlation between the novel EIT-liver device derived data and liver stiffness obtained from transient elastography (a well-established ultrasound-based imaging for liver fat and fibrosis quantification)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Jan 2022
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Gense Technologies Ltd., Innovation and Technology Commission, Hong Kong
- Responsible party
- Principal investigator, Dr Lung-Yi Mak Loey, The University of Hong Kong
- Investigators
- Lung-Yi Mak, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189990
- Sponsor's protocol ID
- HKU-DM-MAK-NAFLD01
- Status last verified
- May 2024
- First submitted
- 17 Dec 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Electrical Impedance Tomography (EIT) Effectiveness in Detecting Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT05189990
- Acronym / sponsor ID
- HKU-DM-MAK-NAFLD01
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- electrical impedance, controlled attenuation parameter, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Gense Technologies Ltd., Innovation and Technology Commission, Hong Kong
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (e.g., 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 dB/m which is S0, while mild fatty liver has CAP 248-267 dB/m or S1. Moderate fatty liver has CAP 268-279 dB/m or S2 and lastly severe fatty liver has CAP >279 dB/m 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical impedance tomographyFatty 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. | Diagnostic test | – |
Primary outcome
Optimal electrical impedance tomography (EIT) injection frequencies for fatty liver detection
Time frame: 24 months
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
1 secondary outcome
The performance characteristics of EIT liver device in hepatic steatosis assessment compared to transient elastography
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lung-Yi Mak, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Fatty Liver Disease, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal electrical impedance tomography (EIT) injection frequencies for fatty liver detection (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.