Contrast-enhanced Multispectral Optoacoustic Tomography for Functional Assessment of the Gastrointestinal Transit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Transit-times of different segments of the gastrointestinal tract
研究概览
简要总结
This clinical trial aims to characterize a novel method of imaging the gastrointestinal tract in healthy subjects. The method is using laser-light and soundwaves and it is performed in a similar manner as conventional ultrasound. It is radiation-free and non-invasive.
Participants will ingest food mixed with the clinically-registered dye Indocyanine green. Researchers will measure the signal of the dye over different segments of the gastrointestinal tract, visualizing gastrointestinal transit.
详细描述
This clinical trial aims to assess gastrointestinal transit by using contrast-enhanced multispectral optoacoustic tomography (MSOT). MSOT is able to visualize not only endogenous chromophores like hemoglobin but also exogenous chromophores such as Indocyanine green (ICG). Healthy subjects will ingest three different standardized meals, all of which are mixed with ICG. By measuring the signal intensity of ICG during gastrointestinal transit, gut motility can be assessed non-invasive and radiation free.
The goal is to compare transit times for different standardized meals, which are liquid, mushy, and solid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
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
- •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
- •Chronic or acute diseases of the gastrointestinal tract or symptoms suggesting such a disease
- •Acute diseases requiring treatment
- •Lack of written consent
- •ICG related:
- •Known hypersensitivity to ICG, sodium iodide or iodine.
- •Hyperthyroidism, focal or diffuse thyroid autonomy.
- •Timely close treatment to check thyroid function with ingestion of radioactive iodine (within two weeks before or after the study)
- •Impaired renal function
- •Taking the following medications: Beta blockers, anticonvulsants, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin, any injection containing sodium bisulfite
结局指标
主要结局
Transit-times of different segments of the gastrointestinal tract
时间窗: 2 days
Transit-times of the gastrointestinal passage
次要结局
- Signal-intensity of ICG(2 days)
研究者
Ferdinand Knieling
Dr. med. habil Ferdinand Knieling
University of Erlangen-Nürnberg Medical School