NCT06975579Recruiting
The COherence of Scatter Identification and Exclusion Algorithm Study
A Study of the COherence of Scatter Identification and Exclusion Algorithm: The COSIE Study
Source: ClinicalTrials.gov · Last updated 16 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 15 (estimated)
- First submitted
- 2 May 2025
- Start date
- 27 Aug 2024
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06975579
What you commit to
- Study type: Observational
- Planned participants: 15
- From 27 Aug 2024 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Healthy Volunteers:
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Royal Marsden Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.