Blood-brain Barrier Permeability Study in Adults With Meningitis
NCT ID: NCT02902588
Last Updated: 2018-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
20 participants
INTERVENTIONAL
2015-08-01
2018-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MRI Study of Radiation-Induced Damage to White Matter and Blood-Brain-Barrier
NCT01988675
Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging Systems
NCT07296263
Glymphatic Kinetics In Healthy Adult Volunteers
NCT03218111
Feasibility Study of New MRI Protocol in Assessing Early Blood Brain Barrier Disruption (BBBD)in Related to Delay Brain Edema
NCT01830894
Measuring Cerebral Blood Flow Using Pseudo-continuous Arterial Spin Labeling Perfusion Magnetic Resonance Imaging
NCT02767609
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
FACTORIAL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ICG washout kinetics assessment
Intravenous administration of 5-10 mg indocyanine green (ICG-PULSION), once per subject
ICG-PULSION
Intravenous administration of indocyanine green
Pulse oximeter monitor
Monitoring of a person's oxygen saturation (SO2), peripheral oxygen saturation
LiMON, Pulsion Medical Systems
Application of near infrared light
Gadolinium washout kinetics assessment
20 mL of gadolinium (Gadovist, Bayer, Germany) injection at 5 mL/s, once per subject
Gadolinium (Gadovist, Bayer, Germany)
Injection of gadolinium
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ICG-PULSION
Intravenous administration of indocyanine green
LiMON, Pulsion Medical Systems
Application of near infrared light
Gadolinium (Gadovist, Bayer, Germany)
Injection of gadolinium
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* diagnosed with meningitis in the examination of cerebrospinal fluid
Exclusion Criteria
* a lack of consent to the test
* liver failure and kidney failure
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Adam Liebert, Prof.
Role: STUDY_CHAIR
Nalecz Institute of Biocybernetics and Biomedical Engineering Polish Academy of Science
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University in Bialystok
Bialystok, , Poland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ergin A, Wang M, Zhang JY, Bruce JN, Fine RL, Bigio IJ, Joshi S. The feasibility of real-time in vivo optical detection of blood-brain barrier disruption with indocyanine green. J Neurooncol. 2012 Feb;106(3):551-60. doi: 10.1007/s11060-011-0711-5. Epub 2011 Oct 1.
Liebert A, Milej D, Weigl W, Gerega A, Kacprzak M, Maniewski R. Fluorescence-based method for assessment of blood-brain barrier disruption. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:3040-2. doi: 10.1109/EMBC.2013.6610181.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BBBP-1PW5
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.