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

October 17, 2018 updated by: Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bialystok, Poland, 15-089
        • Medical University in Bialystok

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICG washout kinetics assessment
Intravenous administration of 5-10 mg indocyanine green (ICG-PULSION), once per subject
Other: ICG-PULSION
Intravenous administration of indocyanine green
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Chair: Adam Liebert, Prof., Nalecz Institute of Biocybernetics and Biomedical Engineering Polish Academy of Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

September 11, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

October 18, 2018

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBBP-1PW5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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