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Trial record 84 of 579 for:    meningitis

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

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ClinicalTrials.gov Identifier: NCT02902588
Recruitment Status : Terminated (The tests have been completed)
First Posted : September 16, 2016
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences

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).

Condition or disease Intervention/treatment Phase
Blood-Brain Barrier Permeability Other: ICG-PULSION Device: LiMON, Pulsion Medical Systems Other: Gadolinium (Gadovist, Bayer, Germany) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : August 1, 2015
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902588


Locations
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Poland
Medical University in Bialystok
Bialystok, Poland, 15-089
Sponsors and Collaborators
Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
Investigators
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Study Chair: Adam Liebert, Prof. Nalecz Institute of Biocybernetics and Biomedical Engineering Polish Academy of Science

Publications of Results:
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Responsible Party: Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
ClinicalTrials.gov Identifier: NCT02902588     History of Changes
Other Study ID Numbers: BBBP-1PW5
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences:
Blood-Brain Barrier
Magnetic Resonance Imaging
Spectroscopy, Near-Infrared
Indocyanine green

Additional relevant MeSH terms:
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Meningitis
Central Nervous System Diseases
Nervous System Diseases