Blood-brain Barrier Permeability Study in Adults With Meningitis (NM-BBBP)

Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences

Status: Terminated

Conditions: Blood-Brain Barrier Permeability

Treatments: Other: Gadolinium (Gadovist, Bayer, Germany); Other: ICG-PULSION; Device: LiMON, Pulsion Medical Systems

Study type: Interventional

Funder types: Other

Identifiers

NCT02902588

BBBP-1PW5

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

ICG washout kinetics assessment

Experimental group

Description:

Intravenous administration of 5-10 mg indocyanine green (ICG-PULSION), once per subject

Treatment:

Other: ICG-PULSION

Pulse oximeter monitor

Other group

Description:

Monitoring of a person's oxygen saturation (SO2), peripheral oxygen saturation

Treatment:

Device: LiMON, Pulsion Medical Systems

Gadolinium washout kinetics assessment

Experimental group

Description:

20 mL of gadolinium (Gadovist, Bayer, Germany) injection at 5 mL/s, once per subject

Treatment:

Other: Gadolinium (Gadovist, Bayer, Germany)