Blood-brain Barrier Permeability Study in Adults With Meningitis (NM-BBBP)
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|ClinicalTrials.gov Identifier: NCT02902588|
Recruitment Status : Terminated (The tests have been completed)
First Posted : September 16, 2016
Last Update Posted : October 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Blood-Brain Barrier Permeability||Other: ICG-PULSION Device: LiMON, Pulsion Medical Systems Other: Gadolinium (Gadovist, Bayer, Germany)||Not Applicable|
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.
3. 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||August 1, 2015|
|Actual Primary Completion Date :||January 31, 2018|
|Actual Study Completion Date :||January 31, 2018|
Experimental: ICG washout kinetics assessment
Intravenous administration of 5-10 mg indocyanine green (ICG-PULSION), once per subject
Intravenous administration of indocyanine green
Pulse oximeter monitor
Monitoring of a person's oxygen saturation (SO2), peripheral oxygen saturation
Device: LiMON, Pulsion Medical Systems
Application of near infrared light
Experimental: Gadolinium washout kinetics assessment
20 mL of gadolinium (Gadovist, Bayer, Germany) injection at 5 mL/s, once per subject
Other: Gadolinium (Gadovist, Bayer, Germany)
Injection of gadolinium
- Correlation between blood brain barrier permeability assessment with use of near infrared spectroscopy and magnetic resonance imaging [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902588
|Medical University in Bialystok|
|Bialystok, Poland, 15-089|
|Study Chair:||Adam Liebert, Prof.||Nalecz Institute of Biocybernetics and Biomedical Engineering Polish Academy of Science|