MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)NCT07321925
Thermoacoustic Method for Estimating Liver Fat Fraction
An observational study of MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis) and Fatty Liver Disease, Nonalcoholic, run by Endra Lifesciences at 1 site in United States.
Trial summary
The goal of this study is to use our Thermoacoustic Enhanced Ultrasound device to measure the fat levels in your liver and compare it to the the gold standard MRI PDFF measurements. Participants will have a scan with our device, then they will go have an abdominal MRI completed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), Fatty Liver Disease, Nonalcoholic
- What is being tested?
- Thermoacoustic Enhanced Ultrasound
- Type of treatment
- Medical device
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study Participants will be from the local general population with focus on potential study participants with known, or clinically suspected, elevated fatty liver
Who may be able to join
- Study participants are 18 or older.
- Able to understand, read, and provide written informed consent in English.
- Able to tolerate both ultrasound and MRI examinations.
- Able to lie flat, or on their side, for 20 minutes and pause breathing for up to 10 seconds.
Who cannot join
- Metal or electronic implants, including, but not limited to: pacemakers, metal clips, drug delivery pumps, hip implants, and neural stimulation devices, contraindicates for MRI.
- Known pregnancy the day of consent or becoming pregnant during study participation based on start date of last menstrual period).
- Liver diseases other than MASLD/MASH/fibrosis including, but not limited to:
- Cirrhosis
- Hepatocellular carcinoma
- Ascites
Show all 13Show fewer
- Patients with broken, or injured skin, in the right upper abdominal quadrant.
- Body habitus, or anatomical variation, where the liver capsule is not accessible with ultrasound through the patient's right intercostal imaging window used in conventional ultrasound liver imaging.
- BMI greater than 50 kg/m2
- Patients with subcutaneous fat at measurement location less than or equal to 6mm.
- Patients with a missing liver lobe.
- Patients with peri-hepatic fat in the measurement location.
- Patients with focal liver lesions or anatomical structures in the measurement location, as detected by ultrasound.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
ENDRA Life Sciences
Ann Arbor, Michigan, 48105
Ava Ohlgren, 734-210-0129, aohlgren@endrainc.com
Chris Bull, 734-210-0129, cbull@endrainc.com
About this study
Official title: Thermoacoustic Method for Estimating Liver Fat Fraction - Pilot Study I
The goal of this study is to use our Thermoacoustic Enhanced Ultrasound device to measure the fat levels in your liver and compare it to the the gold standard MRI PDFF measurements. Participants will have a scan with our device, then they will go have an abdominal MRI completed. The goal is to create a more accessible device to measure liver fat as it is an indicator for overall health and metabolic diseases.
Read the detailed description
The study will perform thermoacoustic fat measurements for up to 80 participants, over the span of the study. MRI-PDFF sequences will be acquired for participants in the study to establish a true measure of liver fat content, per the MRI gold standard. Determine the correlation between FLIP CID system Fat fraction results and the MRI-PDFF. Determine the accuracy between the fat measures obtained by the FLIP CID system participants who received a quantitative MRI. The following additional parameters will be evaluated endpoints: Sensitivity, Specificity ,Positive and negative predictive value (PPV, NPV) and The area under the ROC curve for the detection of liver fat abnormalities
- Conditions
- MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), Fatty Liver Disease, Nonalcoholic
- Being tested
- Thermoacoustic Enhanced Ultrasound
- Keywords
- Fatty Liver, MASLD, MASH, Thermoacoustic
- 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.
Thermoacoustic Enhanced UltrasoundDevice
a novel Thermoacoustic Enhanced imaging device
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Thermoacoustic Fat Fraction (TAFF) and the MRI-PDFF
The correlation between TAFF and the MRI-PDFF, will be conducted using the calculation of the cumulative distribution of the correlation coefficient as derived by Guenther
Measured: From enrollment until the statistical analysis is reviewed, typically 2 weeks after last MRI data is received.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Aug 2025
- Primary completion30 Oct 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endra Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321925
- Sponsor's protocol ID
- ENDRA-CL25-01
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 7 Jan 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermoacoustic Method for Estimating Liver Fat Fraction - Pilot Study I
- ClinicalTrials.gov ID
- NCT07321925
- Acronym / sponsor ID
- ENDRA-CL25-01
- Conditions
- MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), Fatty Liver Disease, Nonalcoholic
- Keywords
- Fatty Liver, MASLD, MASH, Thermoacoustic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Endra LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Jan 2026 (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 goal of this study is to use our Thermoacoustic Enhanced Ultrasound device to measure the fat levels in your liver and compare it to the the gold standard MRI PDFF measurements. Participants will have a scan with our device, then they will go have an abdominal MRI completed. The goal is to create a more accessible device to measure liver fat as it is an indicator for overall health and metabolic diseases.
Detailed description
The study will perform thermoacoustic fat measurements for up to 80 participants, over the span of the study. MRI-PDFF sequences will be acquired for participants in the study to establish a true measure of liver fat content, per the MRI gold standard. Determine the correlation between FLIP CID system Fat fraction results and the MRI-PDFF. Determine the accuracy between the fat measures obtained by the FLIP CID system participants who received a quantitative MRI. The following additional parameters will be evaluated endpoints: Sensitivity, Specificity ,Positive and negative predictive value (PPV, NPV) and The area under the ROC curve for the detection of liver fat abnormalities
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study Participants will be from the local general population with focus on potential study participants with known, or clinically suspected, elevated fatty liver
Key inclusion criteria (4 listed)
- Study participants are 18 or older.
- Able to understand, read, and provide written informed consent in English.
- Able to tolerate both ultrasound and MRI examinations.
- Able to lie flat, or on their side, for 20 minutes and pause breathing for up to 10 seconds.
Key exclusion criteria (13 listed)
- Metal or electronic implants, including, but not limited to: pacemakers, metal clips, drug delivery pumps, hip implants, and neural stimulation devices, contraindicates for MRI.
- Known pregnancy the day of consent or becoming pregnant during study participation based on start date of last menstrual period).
- Liver diseases other than MASLD/MASH/fibrosis including, but not limited to:
- Cirrhosis
- Hepatocellular carcinoma
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 |
|---|---|---|
| Thermoacoustic Enhanced Ultrasounda novel Thermoacoustic Enhanced imaging device | Device | – |
Primary outcome
Correlation between Thermoacoustic Fat Fraction (TAFF) and the MRI-PDFF
Time frame: From enrollment until the statistical analysis is reviewed, typically 2 weeks after last MRI data is received.
The correlation between TAFF and the MRI-PDFF, will be conducted using the calculation of the cumulative distribution of the correlation coefficient as derived by Guenther
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 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.
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 MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis) and Fatty Liver Disease, Nonalcoholic, run by Endra Lifesciences 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 13 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: looking for participants now, as of the sponsor's last update on 7 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ziad Rouag (415-531-4647, zrouag@endrainc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Thermoacoustic Fat Fraction (TAFF) and the MRI-PDFF (time frame: From enrollment until the statistical analysis is reviewed, typically 2 weeks after last MRI data is received.). 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 7 Jan 2026.