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NCT Number: NCT06975579

The COherence of Scatter Identification and Exclusion Algorithm 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal Marsden Hospital

London, Greater London, SM2 5NG, United Kingdom

Location status: Recruiting

Location contact

emma Harris

CONTACT

[email protected]

+442087224576

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound image processing

Device

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma J Harris, PhD

CONTACT

[email protected]

+442087224576

Sponsors and collaborators

Lead sponsor

Institute of Cancer Research, United Kingdom

Other

Collaborators

  • Imperial College London
  • Royal Marsden NHS Foundation Trust

Registry information

Official study title

A Study of the COherence of Scatter Identification and Exclusion Algorithm: The COSIE Study

Acronym: COSIE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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