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Clinical Trial NCT07270601 (LYNX) for MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD - Non-Alcoholic Fatty Liver Disease is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis (LYNX) 110 Non-Invasive Biomarker-Driven

Recruiting
Clinical Trial NCT07270601 (LYNX) is an interventional study for MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD - Non-Alcoholic Fatty Liver Disease that is recruiting. It started on November 17, 2025 with plans to enroll 110 participants. Led by ContextVision AB, it is expected to complete by December 31, 2026. The latest data from ClinicalTrials.gov was last updated on December 8, 2025.
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 hea...Show More
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 patien...Show More
Official Title

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

Conditions
MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseNAFLD - Non-Alcoholic Fatty Liver Disease
Other Study IDs
  • LYNX
  • COV-POCUS-001
NCT ID Number
NCT07270601
Start Date (Actual)
2025-11-17
Last Update Posted
2025-12-08
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
110
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
MASLD
NAFLD
Ultrasound
Steatosis
Fibrosis
MRI-PDFF
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalCohort
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.
Verasonics NXT Data Acquisition System
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
A premium ultrasound system with software package to support imaging research studies.
EchoSense FibroScan
A non-invasive ultrasound solution that accurately measures liver stiffness and liver steatosis.
Philips 3T Ingenia Elition
A 3-tesla magnetic resonance imaging (MRI) system
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Multiparametric Ultrasound Biomarker vs. MR-PDFF
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.
1 year
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Individual Ultrasound parameter vs. MRI-PDFF
Evaluation of each ultrasound parameter (backscatter, attenuation and speed of sound) fat percentage values separately against MRI-PDFF.
1 year
Ultrasound Shear Wave vs MR Elastography
Evaluation of ultrasound shear wave elastography-derived tissue stiffness values in kilopascals compared to MR elastography.
1 year
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes

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.)

  • 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
ContextVision AB logoContextVision AB
University of Washington logoUniversity of Washington
Study Central Contact
Contact: Laura Sissons-Ross Research Manager, 206-616-0397, [email protected]
1 Study Locations in 1 Countries

Washington

University of Washington, Seattle, Washington, 98195, United States
Research Fellow, Contact, 206-616-0397, [email protected]
Rotonya Carr, MD, Principal Investigator
Manish Dhyani, MD, Principal Investigator
Recruiting