Using ultrasound to improve detection of non-alcoholic fatty liver disease

A Study of the COherence of Scatter Identification and Exclusion Algorithm: The COSIE Study

This study is trying to see if a new ultrasound method can help find non-alcoholic fatty liver disease earlier and more accurately in both healthy people and patients getting liver MRIs.

Quick facts

• Study type: Observational
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institute of Cancer Research, United Kingdom (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (London, Greater London)
• Trial ID: NCT06975579 on ClinicalTrials.gov

What this trial studies

This observational study aims to enhance the detection of non-alcoholic fatty liver disease (NAFLD) using an algorithm called COSIE, which improves the accuracy of ultrasound measurements of liver tissue. The study will involve healthy volunteers and patients undergoing liver MRI, focusing on the backscatter coefficient (BSC) to identify steatosis. By refining the measurement process, the study seeks to enable earlier and more reliable detection of NAFLD, which is increasingly prevalent due to common cancer therapies. The approach leverages existing ultrasound technology, making it a cost-effective screening tool.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and above with evidence of steatosis on a preceding MRI or healthy volunteers who consider themselves fit and healthy.

Not a fit: Patients with severe liver fibrosis or cirrhosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate detection of NAFLD, improving patient outcomes and management.

How similar studies have performed: Other studies have shown promise in using ultrasound for detecting liver conditions, but the specific algorithm COSIE is a novel approach.

Eligibility criteria

Inclusion Criteria:

Healthy Volunteers:

* Healthy male or female adults (18 or above).
* Volunteers must consider themselves fit and healthy.
* RMH and/or ICR employees.

Patients:

* Patients undergoing liver MRI as part of clinical standard of care with evidence of steatosis on preceding MRI.
* Aged 18 and above.

Exclusion Criteria:

Healthy Volunteers:

* Volunteers that are under investigation or planning to consult their GP to seek investigation for an undiagnosed condition, particularly regarding pelvic or abdominal disease or injury.
* Healthy volunteers who do not have an NHS number or who are not registered with a GP will be excluded.

Patients:

• Severe liver fibrosis (fibrosis stage F4) or severe cirrhosis.

Where this trial is running

London, Greater London

• The Royal Marsden Hospital — London, Greater London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Emma J Harris, PhD

Conditions Steatohepatitis, Nonalcoholic; Liver ultrasound; backscatter coefficient; Non-alcoholic fatty liver disease; steatosis