Steatohepatitis, Nonalcoholic
Conditions
Keywords
Liver ultrasound, backscatter coefficient, Non-alcoholic fatty liver disease, steatosis
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.
Interventions
DEVICEUltrasound image processing
The COSIE study examines the coherence of ultrasound to improve the estimation of the backscatter coefficient.
Sponsors
Imperial College London
Royal Marsden NHS Foundation Trust
Institute of Cancer Research, United Kingdom
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in backscatter coefficient | up to 6 months | Mean difference in repeat measures of backscatter coefficient (BSC) in the liver with and without application of COSIE, across all participants and all views. |
Countries
United Kingdom
Contacts
Primary ContactEmma J Harris, PhD
Outcome results
None listed