The COherence of Scatter Identification and Exclusion Algorithm Study

NCT06975579 | Recruiting

• 2 other identifiers: CCR 591224/NW/0086
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Steatohepatitis, Nonalcoholic

Keywords

Liver ultrasound; backscatter coefficient; Non-alcoholic fatty liver disease; steatosis

Outcome Measures

Primary Outcomes (1)

• Difference in backscatter coefficient

  Mean difference in repeat measures of backscatter coefficient (BSC) in the liver with and without application of COSIE, across all participants and all views.

  up to 6 months

Study Arms (2)

Healthy Volunteers

Staff at Royal Marsden Hospital or Institute of Cancer Research

Device: Ultrasound image processing

Patients

Patients undergoing therapy/follow up for cancer with some evidence of non-alcoholic fatty liver disease.

Device: Ultrasound image processing

Interventions

Ultrasound image processing DEVICE

The COSIE study examines the coherence of ultrasound to improve the estimation of the backscatter coefficient.

Healthy Volunteers; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

It is assumed that these volunteers will display a range of liver fat fractions and that there may be bias towards the low-fat fractions (\< 5%). Patients with known fatty liver are included to present a broader range of cases to consider, thereby improving the analysis. If a patient is MR scanned and it is found that they have low fat fraction, we will aim to replace them with another patient that does have a high fat fraction. This number has been selected without a priori predictions of the expected variance in results. This study will help to determine the necessary study power required for future investigations. This population size has been selected based on practical considerations, i.e. cost of MR and length of the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• Imperial College London: collaborator
• Royal Marsden NHS Foundation Trust: collaborator

Study Sites (1)

The Royal Marsden Hospital

London, Greater London, SM2 5NG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Central Study Contacts

Emma J Harris, PhD

CONTACT

+442087224576; emma.harris@icr.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 16, 2025
• Study Start: August 27, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)