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NCT02902588: NM-BBBP

Blood-brain Barrier Permeability Study in Adults With Meningitis

Terminated NA Last updated 18 October 2018
What this trial tests

NA trial testing ICG-PULSION in Blood-Brain Barrier Permeability in 20 participants. Terminated before completion.

Timeline
1 August 2015
Primary endpoint
31 January 2018
31 January 2018

Quick facts

Lead sponsorNalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designfactorial
Maskingnone
Primary purposediagnostic
Enrollment20
Start date1 August 2015
Primary completion31 January 2018
Estimated completion31 January 2018
Sites1 location across Poland

Drugs / interventions tested

Conditions studied

Sponsor

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

Who can join

18 and older, any sex, with Blood-Brain Barrier Permeability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Current Strategies to Enhance Delivery of Drugs across the Blood-Brain Barrier.
    Teleanu RI, Preda MD, Niculescu AG, Vladâcenco O, et al · · 2022 · cited 122× · PMID 35631573 · DOI 10.3390/pharmaceutics14050987

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