Steatohepatitis, NonalcoholicCOSIENCT06975579
The COherence of Scatter Identification and Exclusion Algorithm Study
An observational study of Steatohepatitis, Nonalcoholic, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Steatohepatitis, Nonalcoholic
- What is being tested?
- Ultrasound image processing
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Aug 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden Hospital
London, Greater London, SM2 5NG
emma Harris, +442087224576, emma.harris@icr.ac.uk
About this study
Official title: A Study of the COherence of Scatter Identification and Exclusion Algorithm: The COSIE Study
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
- Being tested
- Ultrasound image processing
- Keywords
- Liver ultrasound, backscatter coefficient, Non-alcoholic fatty liver disease, steatosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound image processingDevice
The COSIE study examines the coherence of ultrasound to improve the estimation of the backscatter coefficient.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Staff at Royal Marsden Hospital or Institute of Cancer Research Receives: Device: Ultrasound image processing | |
| Patients | Patients undergoing therapy/follow up for cancer with some evidence of non-alcoholic fatty liver disease. Receives: Device: Ultrasound image processing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start27 Aug 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steatohepatitis, NonalcoholicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, Royal Marsden NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975579
- Sponsor's protocol ID
- CCR 5912
- Other IDs
- 24/NW/0086
- Acronym
- COSIE
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised ultrasound and MR images will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the COherence of Scatter Identification and Exclusion Algorithm: The COSIE Study
- ClinicalTrials.gov ID
- NCT06975579
- Acronym / sponsor ID
- COSIE / CCR 5912
- Conditions
- Steatohepatitis, Nonalcoholic
- Keywords
- Liver ultrasound, backscatter coefficient, Non-alcoholic fatty liver disease, steatosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Imperial College London, Royal Marsden NHS Foundation Trust
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Device: Ultrasound image processingStaff at Royal Marsden Hospital or Institute of Cancer Research |
| Patients | – | Device: Ultrasound image processingPatients undergoing therapy/follow up for cancer with some evidence of non-alcoholic fatty liver disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Healthy male or female adults (18 or above).
- Volunteers must consider themselves fit and healthy.
- RMH and/or ICR employees.
- Patients undergoing liver MRI as part of clinical standard of care with evidence of steatosis on preceding MRI.
- Aged 18 and above.
Key exclusion criteria (5 listed)
- 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.
- Severe liver fibrosis (fibrosis stage F4) or severe cirrhosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound image processingThe COSIE study examines the coherence of ultrasound to improve the estimation of the backscatter coefficient. | Device | Healthy Volunteers, Patients |
Primary outcome
Difference in backscatter coefficient
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: Yes. Anonymised ultrasound and MR images will be shared upon request.
Related trials for Steatohepatitis, Nonalcoholic
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
RecruitingPhase 3
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Not yet recruitingPhase 2
Qurse Revand for MASLD: A Randomized Controlled Safety and Efficacy Trial
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Steatohepatitis, Nonalcoholic, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma J Harris, PhD (+442087224576, emma.harris@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in backscatter coefficient (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.