The Use of Near Infrared Spectroscopy and Magnetic Resonance Imaging Technique in the Evaluation of the Permeability of Blood-brain Barrier in Adults With Meningitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Correlation between blood brain barrier permeability assessment with use of near infrared spectroscopy and magnetic resonance imaging
研究概览
简要总结
The purpose of the study is to confirm the applicability and usefulness of the novel method of assessment of the permeability of the blood-brain barrier and in monitoring of the treatment of patients with meningitis. The proposed technique is based on evaluation of the kinetics of the indocyanine green (ICG) outflow from the brain with the use of near-infrared spectroscopy (NIRS). Usefulness of the NIRS-based method will be analyzed in relation to the reference method, which is contrast-enhanced magnetic resonance imaging (MRI).
详细描述
Clinical trials in healthy volunteers and in patients with diagnosed blood-brain barrier disruption:
- Performing a lumbar puncture as a routine diagnostic procedure in a patient with suspected neuroinfection. Biochemical assessment of the degree of the blood-brain barrier disruption based on the albumin ratio.
- Enrollment of patients diagnosed with neuroinfection to the study and obtaining informed consent.
- Performing the measurement involving fixation of the NIRS probes on the patient's head while intravenously injecting optical contrast agent - ICG (5-10 mg in a bolus). The measurement time is about 15 min. Monitoring of the patient's condition during the examination using a pulse oximeter monitor. The examination should be performed no later than 12 hours after the lumbar puncture to obtain a reliable correlation of results between the methods. The party responsible for the technical aspect of the investigation will be the Sponsor while the party responsible for the medical aspect (including the injection of the contrast agent) will be the Principal Investigator.
- Conducting a magnetic resonance test. The MRI imaging can be carried out before or after the test by the optical method, but with only a slight time delay (not more than 24h). The gadolinium will be injected at 5 mL/s (20 mL per patient). Calculating the cerebral blood flow and the cerebrovascular permeability coefficient and passing the information to the patient's doctor.
- The assessment of the contrast agent outflow kinetics parameters obtained with use of the optical method 4. The correlation of the results of the of the evaluation of the blood-brain barrier condition by MRI, biochemical assessment of the cerebro-spinal fluid and optical method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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
- •patients over 18 years old
- •diagnosed with meningitis in the examination of cerebrospinal fluid
排除标准
- •allergic to any of the contrast agents
- •a lack of consent to the test
- •liver failure and kidney failure
研究组 & 干预措施
ICG washout kinetics assessment
Intravenous administration of 5-10 mg indocyanine green (ICG-PULSION), once per subject
干预措施: ICG-PULSION (Other)
Pulse oximeter monitor
Monitoring of a person's oxygen saturation (SO2), peripheral oxygen saturation
干预措施: LiMON, Pulsion Medical Systems (Device)
Gadolinium washout kinetics assessment
20 mL of gadolinium (Gadovist, Bayer, Germany) injection at 5 mL/s, once per subject
干预措施: Gadolinium (Gadovist, Bayer, Germany) (Other)
结局指标
主要结局
Correlation between blood brain barrier permeability assessment with use of near infrared spectroscopy and magnetic resonance imaging
时间窗: up to 12 months
The kinetics of the indocyanine green (ICG) outflow from the brain with the use of near-infrared spectroscopy will be a subject of investigation. ICG washout rate parameter R \[a.u.\] will be calculated which describes the effectiveness of the washout of ICG from the brain. It is calculated by measuring the accumulation of ICG contrast agent in the extravascular-extracellular space. The volume transfer constant (Ktrans) which reflects the efflux rate of gadolinium contrast from blood plasma into the tissue extravascular-extracellular space will be assessed during contrast-enhanced magnetic resonance imaging study. Ktrans is a measure of capillary permeability. Both parameters may reflect blood brain barrier (BBB) permeability and indicate BBB disruption. The primary outcome of the study will be correlation coefficient r \[a.u.\] between R and Ktrans calculated for the set of subjects. Adverse events as a consequence of ICG and/or gadolinium administration will be monitored and reported.
次要结局
未报告次要终点