---
title: Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis
nct_id: NCT07270601
overall_status: RECRUITING
phase: NA
sponsor: ContextVision AB
study_type: INTERVENTIONAL
primary_condition: MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07270601.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07270601"
ct_last_update_post_date: 2025-12-08
last_seen_at: "2026-05-12T07:15:42.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis

**Official Title:** Development and Diagnostic Evaluation of a Novel Quantifiable Ultrasound Based Multi-parametric Biomarker for Hepatic Steatosis in Patients With Suspected MASLD ( LYNX )

**NCT ID:** [NCT07270601](https://clinicaltrials.gov/study/NCT07270601)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 110
- **Lead Sponsor:** ContextVision AB
- **Collaborators:** University of Washington
- **Conditions:** MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD - Non-Alcoholic Fatty Liver Disease
- **Start Date:** 2025-11-17
- **Completion Date:** 2026-12-31
- **CT.gov Last Update:** 2025-12-08

## Brief Summary

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.

## Detailed Description

The objective is to develop a novel multiparametric ultrasound-based technique to quantify the amount of steatosis in the liver by using the current MRI-based gold-standard - MRI proton density fat fraction (MRI-PDFF) as a clinical reference. This clinical development study will only collect the required dataset from healthy volunteers and subjects with different degrees of steatosis in the liver, particularly patients with MASLD, formerly non-alcoholic fatty liver disease (NAFLD). It will capture the raw radiofrequency data required for the development of this new radiologic biomarker on a research ultrasound imaging device. In addition, various other clinical and radiological datasets will be captured to support the ground truthing, development and training of the novel ultrasound-based multiparametric biomarker.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

Diseased subject:

* Adult patients (age 18 - 75 years)
* Consent to participate in the study
* Diagnosed or suspected MASLD from the hepatology clinic, OR
* High-risk population meeting the adult cardiometabolic criteria (defined as the presence of at least one of the following: diabetes, obesity (BMI ≥ 25 kg/m2), hypercholesterolemia, and hypertension)

Healthy volunteer:

* Adult patients (age 18 - 75 years)
* Consent to participate in the study
* No suspicion of MASLD by laboratory/imaging/clinical examinations
* Absence of known pre-existing conditions (metabolic syndrome, diabetes mellitus, obesity, insulin resistance, dyslipidemia, etc.)

Exclusion Criteria:

* Pregnancy or nursing.
* Contraindications to MRI including, but not limited to, severe claustrophobia, pacemaker, or existing metallic/mechanical implant(s).
* Acute illness/cognitive impairment resulting in an inability to cooperate with the MRI and ultrasound breath-holding instructions.
* BMI \> 35 kg/m2
* History of excessive alcohol consumption according to the updated MASLD criteria (\>2 drinks/day OR \>210 grams/week for males AND \>1 drink/day OR \>140 grams/week for females) or drug use over the past 2 years.
* Known acute or chronic hepatitis; or other etiology of liver disease.
* Presence of known congenital hepatic anomaly.
* Known cirrhosis
* Known active cancer
```

## Arms

- **Cohort** (EXPERIMENTAL) — Adult healthy volunteers as well as subjects who have a diagnosis, or suspected, of having MASLD or are deemed to meet the high-risk cardiometabolic criteria.

## Interventions

- **Verasonics NXT Data Acquisition System** (DEVICE) — A research ultrasound imaging device to capture raw radiofrequency ultrasound data for the following parameters:

* B-mode imaging
* Attenuation coefficient
* Backscatter coefficient
* Speed of sound
* Shear wave elastography
- **Philips EPIQ Elite** (DEVICE) — A premium ultrasound system with software package to support imaging research studies.
- **EchoSense FibroScan** (DEVICE) — A non-invasive ultrasound solution that accurately measures liver stiffness and liver steatosis.
- **Philips 3T Ingenia Elition** (DEVICE) — A 3-tesla magnetic resonance imaging (MRI) system

## Primary Outcomes

- **Multiparametric Ultrasound Biomarker vs. MR-PDFF** _(time frame: 1 year)_ — Clinical qualification of the multiparametric ultrasound-derived fat fraction, defined as its agreement with the established clinical reference, MRI proton density fat fraction (MRI-PDFF) expressed as absolute percentage, in bench testing analysis.

## Secondary Outcomes

- **Individual Ultrasound parameter vs. MRI-PDFF** _(time frame: 1 year)_
- **Ultrasound Shear Wave vs MR Elastography** _(time frame: 1 year)_

## Locations (1)

- University of Washington, Seattle, Washington, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `eligibility.maxAge` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of washington|seattle|washington|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07270601.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07270601*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*