This trial is active, not recruiting.

Condition blood-brain barrier permeability
Treatments icg-pulsion, limon, pulsion medical systems, gadolinium (gadovist, bayer, germany)
Sponsor Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
Start date August 2016
End date December 2017
Trial size 40 participants
Trial identifier NCT02902588, BBBP-1PW5


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model factorial assignment
Masking open label
Primary purpose diagnostic
Intravenous administration of 5-10 mg indocyanine green (ICG-PULSION), once per subject
Intravenous administration of indocyanine green
Monitoring of a person's oxygen saturation (SO2), peripheral oxygen saturation
limon, pulsion medical systems
Application of near infrared light
20 mL of gadolinium (Gadovist, Bayer, Germany) injection at 5 mL/s, once per subject
gadolinium (gadovist, bayer, germany)
Injection of gadolinium

Primary Outcomes

Correlation between blood brain barrier permeability assessment with use of near infrared spectroscopy and magnetic resonance imaging
time frame: up to 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences.