Blood-Brain Barrier Permeability Clinical Trial
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
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).
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02033291 -
Blood-brain Barrier Quantification in Cerebral Small Vessel Disease
|
N/A |