Clinical trial NCT02902588: Blood-brain Barrier Permeability Study in Adults With Meningitis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Blood-Brain Barrier Permeability
Keywords: Blood-Brain Barrier
Magnetic Resonance Imaging
Spectroscopy, Near-Infrared
Indocyanine green
Lead sponsor: Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients over 18 years old
* diagnosed with meningitis in the examination of cerebrospinal fluid

Exclusion Criteria:

* allergic to any of the contrast agents
* a lack of consent to the test
* liver failure and kidney failure

Primary outcomes:
measure: Correlation between blood brain barrier permeability assessment with use of near infrared spectroscopy and magnetic resonance imaging
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: Medical University in Bialystok
Study officials:
affiliation: Nalecz Institute of Biocybernetics and Biomedical Engineering Polish Academy of Science
name: Adam Liebert, Prof.
role: STUDY_CHAIR
References:
citation: Ergin A, Wang M, Zhang JY, Bruce JN, Fine RL, Bigio IJ, Joshi S. The feasibility of real-time in vivo optical detection of blood-brain barrier disruption with indocyanine green. J Neurooncol. 2012 Feb;106(3):551-60. doi: 10.1007/s11060-011-0711-5. Epub 2011 Oct 1.
citation: Liebert A, Milej D, Weigl W, Gerega A, Kacprzak M, Maniewski R. Fluorescence-based method for assessment of blood-brain barrier disruption. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:3040-2. doi: 10.1109/EMBC.2013.6610181.