The COherence of Scatter Identification and Exclusion Algorithm Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound image processing.
- Who it may be relevant to
- Registry conditions: Steatohepatitis, Nonalcoholic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study of the COherence of Scatter Identification and Exclusion Algorithm: The COSIE Study
Overview
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
- Device Ultrasound image processing
The COSIE study examines the coherence of ultrasound to improve the estimation of the backscatter coefficient.
Primary outcome measures
- Difference in backscatter coefficient [Time frame: up to 6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- The Royal Marsden Hospital — London
Identifiers
NCT: NCT06975579 · CCR 5912 · 24/NW/0086