NASHNCT04302051
Assessment of Fatty Liver With Thermo-acoustic Device
An observational study of NASH and NAFLD, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The study will evaluate the accuracy of hepatic steatosis estimation by thermo-acoustic ultrasound with estimation by MRI-PDFF (Proton Density Fat Fraction) . It will also evaluate the sensitivity of this device in the diagnosis of fatty liver. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NASH, NAFLD, Non-alcoholic Fatty Liver
- What is being tested?
- Thermo-acuostic image acquisition of liver and MRI-PDFF estimation of hepatic fat
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2023to 9 Jul 2026
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult volunteers with diagnosed or suspected for non-alcoholic fatty liver disease will be recruited in the study. Patients who meet inclusion and exclusion criteria will be included in the study.
Who may be able to join
- patients diagnosed or suspected to have non-alcoholic fatty liver disease
- Patients 18-70 years of age
- be able to understand and sign on written informed consent
- able to undergo ultrasound and MRI examinations
Who cannot join
- any metal or electronic implants including but not limited to pacemakers, clips, hips
- known history of pregnancy or becoming pregnant during study period
- unable to understand and sign on written informed consent
- intolerant to ultrasound and/or MRI examinations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study for Quantifying Fatty Liver Using Thermo-acoustic Imaging
The study will evaluate the accuracy of hepatic steatosis estimation by thermo-acoustic ultrasound with estimation by MRI-PDFF (Proton Density Fat Fraction) . It will also evaluate the sensitivity of this device in the diagnosis of fatty liver.
Read the detailed description
Patients with either known or presumed diagnosis of non-alcoholic fatty liver disease who meets eligibility criteria will be included in the study. They will have imaging done to estimate hepatic steatosis by two modalities (MRI - PDFF and thermo-acoustic ultrasound). The estimation obtained by thermo-acoustic ultrasound will be compared with MRI results for accuracy of estimation by the thermo-acoustic ultrasound device. The study will also evaluate the sensitivity of the thermo-acoustic ultrasound device if it can diagnose the presence of hepatic steatosis when hepatic fat content is 15% or less by volume.
- Conditions
- NASH, NAFLD, Non-alcoholic Fatty Liver, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, Fatty Liver
- Being tested
- Thermo-acuostic image acquisition of liver, MRI-PDFF estimation of hepatic fat
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermo-acuostic image acquisition of liverDiagnostic test
Estimation of hepatic fat content with thermo-acoustic device
MRI-PDFF estimation of hepatic fatDiagnostic test
Estimation of hepatic fat content with MRI
| Study group | Role | What they receive |
|---|---|---|
| Study Group | The hepatic fat estimation will be performed on the same subjects with the use of the thermo-acoustic device and by MRI-PDFF. The data obtained from the two estimations will be compared. Receives: Diagnostic Test: Thermo-acuostic image acquisition of liver; Diagnostic Test: MRI-PDFF estimation of hepatic fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of hepatic fat estimation by the thermo-acoustic device with MRI-PDFF technique
The study evaluates if the new thermo-acoustic device can accurately estimate the hepatic fat content among patients with non-alcoholic fatty liver disease to the currently approved method using MRI-PDFF scan.
Measured: one year
Secondary outcomes (2)
Evaluate the best and ideal number of the anatomical site for thermo-acoustic evaluation of liver
The study evaluates the number of estimation required and the appropriate anatomical site to evaluate the liver to obtain best results
Measured: One year
Evaluate the sensitivity of the thermo-acoustic device in the diagnosis of hepatic steatosis.
Evaluate the sensitivity of the thermo-acoustic device in diagnosis presence of hepatic steatosis among patients with MRI-PDFF finding of more than 15% hepatic steatosis
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start2 Nov 2023
- Primary completion9 Jul 2026
- Study completion9 Jul 2026
Why it stopped: The sponsor withdrew from the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASHStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- ENDRA Life Sciences, Inc.
- Responsible party
- Principal investigator, Achuthan Sourianarayanane, Medical College of Wisconsin
- Investigators
- ACHUTHAN SOURIANARAYANANE, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302051
- Sponsor's protocol ID
- PRO00036361
- Status last verified
- Jul 2026
- First submitted
- 6 Mar 2020
- Last updated
- 10 Jul 2026
- 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for Quantifying Fatty Liver Using Thermo-acoustic Imaging
- ClinicalTrials.gov ID
- NCT04302051
- Acronym / sponsor ID
- PRO00036361
- Conditions
- NASH, NAFLD, Non-alcoholic Fatty Liver, Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, Fatty Liver
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The sponsor withdrew from the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- ENDRA Life Sciences, Inc.
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 9 Jul 2026 (actual)
- Study completion
- 9 Jul 2026 (actual)
- First posted
- 10 Mar 2020 (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.
The study will evaluate the accuracy of hepatic steatosis estimation by thermo-acoustic ultrasound with estimation by MRI-PDFF (Proton Density Fat Fraction) . It will also evaluate the sensitivity of this device in the diagnosis of fatty liver.
Detailed description
Patients with either known or presumed diagnosis of non-alcoholic fatty liver disease who meets eligibility criteria will be included in the study. They will have imaging done to estimate hepatic steatosis by two modalities (MRI - PDFF and thermo-acoustic ultrasound). The estimation obtained by thermo-acoustic ultrasound will be compared with MRI results for accuracy of estimation by the thermo-acoustic ultrasound device. The study will also evaluate the sensitivity of the thermo-acoustic ultrasound device if it can diagnose the presence of hepatic steatosis when hepatic fat content is 15% or less by volume.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Thermo-acuostic image acquisition of liver, Diagnostic Test: MRI-PDFF estimation of hepatic fatThe hepatic fat estimation will be performed on the same subjects with the use of the thermo-acoustic device and by MRI-PDFF. The data obtained from the two estimations will be compared. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult volunteers with diagnosed or suspected for non-alcoholic fatty liver disease will be recruited in the study. Patients who meet inclusion and exclusion criteria will be included in the study.
Key inclusion criteria (4 listed)
- patients diagnosed or suspected to have non-alcoholic fatty liver disease
- Patients 18-70 years of age
- be able to understand and sign on written informed consent
- able to undergo ultrasound and MRI examinations
Key exclusion criteria (4 listed)
- any metal or electronic implants including but not limited to pacemakers, clips, hips
- known history of pregnancy or becoming pregnant during study period
- unable to understand and sign on written informed consent
- intolerant to ultrasound and/or MRI examinations
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 |
|---|---|---|
| Thermo-acuostic image acquisition of liverEstimation of hepatic fat content with thermo-acoustic device | Diagnostic test | Study Group |
| MRI-PDFF estimation of hepatic fatEstimation of hepatic fat content with MRI | Diagnostic test | Study Group |
Primary outcome
Correlation of hepatic fat estimation by the thermo-acoustic device with MRI-PDFF technique
Time frame: one year
The study evaluates if the new thermo-acoustic device can accurately estimate the hepatic fat content among patients with non-alcoholic fatty liver disease to the currently approved method using MRI-PDFF scan.
2 secondary outcomes
Evaluate the best and ideal number of the anatomical site for thermo-acoustic evaluation of liver
Time frame: One year
Evaluate the sensitivity of the thermo-acoustic device in the diagnosis of hepatic steatosis.
Time frame: One year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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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.
ACHUTHAN SOURIANARAYANANE, MD principal investigator
Medical College of Wisconsin
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 NASH and NAFLD, run by Medical College of Wisconsin at 1 site in United States.
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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 10 Jul 2026. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Correlation of hepatic fat estimation by the thermo-acoustic device with MRI-PDFF technique (time frame: one year). 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 10 Jul 2026.