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Fatty liver disease (NASH/MASH)

Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis

Recruiting · Seattle, Washington

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Interpreters available

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Your choice

Voluntary — you can stop anytime

What is this study?

The research study is considering a non-invasive way to measure the percentage of fat in the liver using ultrasound. This could help detect early signs of a very common condition called metabolic dysfunction-associated steatotic liver disease (MASLD).

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

The research study is considering a non-invasive way to measure the percentage of fat in the liver using ultrasound. This could help detect early signs of a very common condition called metabolic dysfunction-associated steatotic liver disease (MASLD). Current tests, like MRI or biopsy, can be expensive or invasive. If successful, this ultrasound tool could become an easier and more accessible way to monitor liver health - especially for people with obesity, diabetes, high blood pressure, or high cholesterol.

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

  • Adults age 18 to 75.
  • You can join if you have MASLD that was diagnosed or suspected at a liver (hepatology) clinic, or if you are in a higher-risk group (diabetes, obesity, high cholesterol, and/or high blood pressure).
  • Healthy volunteers can join if there is no suspicion of MASLD based on lab tests, imaging, and clinical exam.
  • You must be able to give consent to participate.

🚫 You may not be able to join if…

  • You cannot join if you are pregnant or nursing.
  • You cannot join if you have a reason you can’t safely do MRI (for example, severe claustrophobia, a pacemaker, or metal/mechanical implants).
  • You cannot join if you have an acute illness or cognitive impairment that would make it hard to cooperate with MRI/ultrasound breath-holding instructions.
  • You cannot join if BMI is over 35 kg/m2.
  • You cannot join if you have known cirrhosis, active cancer, hepatitis, or another known cause of liver disease, or if you had very heavy alcohol use or drug use in the past 2 years.

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

  • Adults age 18–75
  • May be enrolled if you’re diagnosed/suspected MASLD or are in a high-risk cardiometabolic group
  • BMI must be 35 or less
  • Not pregnant or nursing
  • No known contraindications to MRI (e.g., some implants/claustrophobia)
  • No known cirrhosis, active cancer, or other major liver disease/acute hepatitis
  • !Not for people who are pregnant or breastfeeding

How this study is designed

The real details, in plain words. Tap the underlined words to learn what they mean.

  • Everyone in this study receives an active treatment — there is no placebo group.

What to expect, step by step

· This study lasts about 52 weeks (~12 months)
  1. 1

    Usually a few weeks

    The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.

  2. 2

    Treatment

    About 52 weeks

    If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.

  3. 3

    Follow-up

    After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

What's being tested

  • Device: Verasonics NXT Data Acquisition System
  • Device: Philips EPIQ Elite
  • Device: EchoSense FibroScan
  • Device: Philips 3T Ingenia Elition

Has this treatment been tested before?

The study team can share what safety testing has been done so far.

Who's running this study?

Sponsor

ContextVision AB

Every study is also reviewed by an independent that protects participants.

What you need to know before you apply

What is this study testing?+

The research study is considering a non-invasive way to measure the percentage of fat in the liver using ultrasound. This could help detect early signs of a very common condition called metabolic dysfunction-associated steatotic liver disease (MASLD).

Is it safe? Who makes sure of that?+

This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.

Source: ClinicalTrials.gov · NCT07270601 · Locations: Washington