跳至主要内容
临床试验/NCT06063785
NCT06063785招募中不适用

Multispectral Optoacoustic Tomography for the Assessment of Liver Fibrosis and Gastrointestinal Transit in Patients With Cystic Fibrosis

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月1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
30
试验地点
1
主要终点
Quantitative collagen signal (Liver)

研究概览

简要总结

Cystic fibrosis (CF) is the most common hereditary disease in Central Europe. The disease is caused by a mutation in the cystic fibrosis transmembrane conductance regulator gene (CFTR). In the liver, fibrotic remodeling can lead to liver cirrhosis in the long term. Early detection of CF hepatopathy is essential to therapeutically slow down the progression of fibrotic remodeling mechanisms. Newborns suffering from CF have a significantly increased risk for the occurrence of meconium ileus and also with advancing age there are symptoms ranging from chronic constipation to Distal Intestinal Obstruction Syndrome (DIOS), due to a reduction of intestinal motility.

In this study, the degree of liver fibrosis will now be investigated in adult patients with cystic fibrosis using Multispectral Optoacoustic Imaging (MSOT). In addition, gastrointestinal passage will be studied non-invasively to investigate another affection of the gastrointestinal system.

详细描述

Cystic fibrosis (CF) is the most common hereditary disease in Central Europe, with an incidence of approximately 3,300 to 4,800 new cases. The disease follows an autosomal recessive pattern of inheritance, the cause being a mutation in the cystic fibrosis transmembrane conductance regulator gene (CFTR). In the liver, fibrotic remodeling can lead to liver cirrhosis in the long term. Early detection of CF hepatopathy is essential to therapeutically slow down the progression of fibrotic remodeling mechanisms. Over the past decade, measurements of liver stiffness using Acoustic Radiation Force Impulse Imaging (ARFI) have proven to be a valid tool for measuring fibrotic tissue remodeling in CF in adults and children. Furthermore, in the gastrointestinal tract, serious consequences result from the absence of the CFTR channel. Newborns suffering from CF have a significantly increased risk for the occurrence of meconium ileus and also with advancing age there are symptoms ranging from chronic constipation to DIOS (Distal Intestinal Obstruction Syndrome), due to a reduction of intestinal motility.

By means of new imaging methods, such as multispectral optoacoustic tomography, it is possible to examine not only the body's own substances but also substances foreign to the body. With Multispectral Optoacoustic Imaging (MSOT), similar to conventional sonography, a transducer is placed on the skin and instead of sound, energy is applied to the tissue by means of light flashes. This leads to a constant alternation of minimal expansions and contractions (thermoelastic expansion) of individual tissue components or molecules. Previous studies have shown that quantitative determination of hemoglobin can provide information on blood flow and inflammatory activity in the intestines of adult patients with Crohn's disease. Also, fibrotic changes in the liver can probably be detected with this method, similar to that in muscle tissue. Furthermore, we have recently shown that orally ingested Indocyanine green (ICG) can be detected in the small intestine and thus conclusions can be drawn about gastrointestinal passage, without the use of ionizing radiation. In this study, the degree of liver fibrosis will now be investigated in adult patients with cystic fibrosis using MSOT. In addition, gastrointestinal passage will be studied non-invasively to investigate another affection of the gastrointestinal system.

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

入选标准

  • Patient cohort "Cystic Fibrosis without CF-related liver disease":
  • Molecular genetic confirmed diagnosis of cystic fibrosis.
  • Age over 18 years
  • Written informed consent
  • Patient cohort "Cystic Fibrosis with CF-related liver disease":
  • Molecular genetic confirmed diagnosis of cystic fibrosis
  • Presence of CF-related liver disease based on Colombo criteria:
  • Hepato- and/or splenomegaly
  • Persistent elevation of transaminases in the serum
  • Sonographic evidence of liver involvement
  • Age over 18 years
  • Written informed consent
  • "Volunteer Subjects":
  • Age over 18 years
  • Written informed consent

排除标准

  • Pregnancy
  • Breastfeeding mothers
  • Tattoo in the area of the examination
  • Subcutaneous fat tissue over 3 cm
  • Patient cohort "Cystic fibrosis without CF-related liver disease":
  • Taking systemic glucocorticoids or immunosuppressants as part of a permanent medication regimen.
  • Presence of CF-related liver disease based on Colombo criteria:
  • Hepato- and/or splenomegaly.
  • Persistent elevation of transaminases in the serum
  • Sonographic evidence of liver involvement.
  • Acute exacerbation of infection
  • Patient cohort "Cystic fibrosis with CF-related liver disease":
  • Taking systemic glucocorticoids or immunosuppressants as part of a permanent medication regimen.
  • Decompensation of CF-related liver disease
  • Acute exacerbation of infection
  • "volunteer subjects":
  • Presence of liver disease
  • Use of systemic glucocorticoids or immunosuppressants in the context of permanent medication

结局指标

主要结局

Quantitative collagen signal (Liver)

时间窗: Day 1

in arbitrary units

Quantitative Indocyanine Green (ICG) signal (Intestinal)

时间窗: 0, 60, 90, 120, 180, 240, 300min post ICG intake

Day 1

次要结局

  • Deoxycholic acid (DCA) and respective glycine and taurine conjugates(Day 1)
  • Shear wave velocity (Liver)(Day 1)
  • Cholic acid (CA) and respective glycine and taurine conjugates(Day 1)
  • Lithocholic acid (LCA) and respective glycine and taurine conjugates(Day 1)
  • Quantitative oxy/deoxygenated hemoglobin signal (Liver)(Day 1)
  • Quantitative single wave lengths (Liver)(Day 1)
  • Optoacoustic spectrum (Intestinal)(0, 60, 90, 120, 180, 240, 300min post ICG intake)
  • Optoacoustic spectrum (Liver)(Day 1)
  • Quantitative single wave lengths (Intestinal)(0, 60, 90, 120, 180, 240, 300min post ICG intake)
  • Attenuation coefficient (Liver)(Day 1)
  • Chenodeoxycholic acid (CDCA) and respective glycine and taurine conjugates(Day 1)
  • Quantitative oxy/deoxygenated hemoglobin signal (Intestinal)(0, 60, 90, 120, 180, 240, 300min post ICG intake)
  • Ursodeoxycholic acid (UDCA) and respective glycine and taurine conjugates(Day 1)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander Schnell

Principal Investigator

University of Erlangen-Nürnberg Medical School

研究点 (1)

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