Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06975579

The COherence of Scatter Identification and Exclusion Algorithm Study

Led by Institute of Cancer Research, United Kingdom · Updated on 2025-05-16

15

Participants Needed

1

Research Sites

43 weeks

Total Duration

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Sponsors

I

Institute of Cancer Research, United Kingdom

Lead Sponsor

I

Imperial College London

Collaborating Sponsor

AI-Summary

What this Trial Is About

Non-alcoholic fatty liver disease (NAFLD) is currently the most common liver condition worldwide; approximately 55% of the world population will have NAFLD by 2040. NAFLD is an unwanted side effect of common cancer therapies, such as chemotherapy. Ultrasound can detect NAFLD via measurement of the backscatter coefficient (BSC). It is an attractive technique because of its low cost and availability, potentially enabling earlier detection of NAFLD in a larger population through screening. This approach has shown promise in detecting NAFLD but is limited by variability in measurement due to several factors. Measurement of the BSC requires assumptions about the nature of the tissue being measured; if these assumptions are incorrect, they can lead to inaccurate BSC measurements. To improve accuracy, an algorithm (COSIE) was developed to quantify the suitability of tissue for BSC analysis. The investigators believe COSIE will enable more reliable BSC measurements by selecting the optimal regions of tissue to measure. By measuring the BSC in the livers of healthy volunteers and patients with evidence of fatty liver, the algorithm can be evaluated against liver fat percentage values obtained from MRI imaging. This study will assess whether applying the COSIE algorithm enhances the reliability of BSC measurements, bringing them closer in quality to MRI imaging.

CONDITIONS

Official Title

The COherence of Scatter Identification and Exclusion Algorithm Study

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy male or female adults aged 18 or above
  • Volunteers who consider themselves fit and healthy
  • RMH and/or ICR employees
  • Patients aged 18 or above undergoing liver MRI as part of clinical standard of care with evidence of steatosis on preceding MRI
Not Eligible

You will not qualify if you...

  • Volunteers currently under investigation or planning to consult their GP for undiagnosed pelvic or abdominal disease or injury
  • Healthy volunteers without an NHS number or not registered with a GP
  • Patients with severe liver fibrosis (fibrosis stage F4) or severe cirrhosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Royal Marsden Hospital

London, Greater London, United Kingdom, SM2 5NG

Actively Recruiting

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Research Team

E

Emma J Harris, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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