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The COherence of Scatter Identification and Exclusion Algorithm Study

NCT06975579 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2025-05-16

No results posted yet for this study

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.

Conditions

  • Steatohepatitis, Nonalcoholic

Interventions

DEVICE

Ultrasound image processing

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

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER

  • Royal Marsden NHS Foundation Trust

    collaborator OTHER

  • Institute of Cancer Research, United Kingdom

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-27
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06975579 on ClinicalTrials.gov