跳至主要内容
临床试验/NCT06975579
NCT06975579招募中不适用

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

Institute of Cancer Research, United Kingdom1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年8月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
15
试验地点
1
主要终点
Difference in backscatter coefficient

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy Volunteers:
  • •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.

排除标准

  • •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.
  • •Severe liver fibrosis (fibrosis stage F4) or severe cirrhosis.

结局指标

主要结局

Difference in backscatter coefficient

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Institute of Cancer Research, United Kingdom
申办方类型
Other
责任方
Sponsor

研究点 (1)

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