NCT02902588

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

2.5 years

First QC Date

August 23, 2016

Last Update Submit

October 17, 2018

Conditions

Blood-Brain Barrier Permeability

Keywords

Blood-Brain BarrierMagnetic Resonance ImagingSpectroscopy, Near-InfraredIndocyanine green

Outcome Measures

Primary Outcomes (1)

  • Correlation between blood brain barrier permeability assessment with use of near infrared spectroscopy and magnetic resonance imaging

    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

Study Arms (3)

ICG washout kinetics assessment

EXPERIMENTAL

Intravenous administration of 5-10 mg indocyanine green (ICG-PULSION), once per subject

Other: ICG-PULSION

Pulse oximeter monitor

OTHER

Monitoring of a person's oxygen saturation (SO2), peripheral oxygen saturation

Device: LiMON, Pulsion Medical Systems

Gadolinium washout kinetics assessment

EXPERIMENTAL

20 mL of gadolinium (Gadovist, Bayer, Germany) injection at 5 mL/s, once per subject

Other: Gadolinium (Gadovist, Bayer, Germany)

Interventions

ICG-PULSIONOTHER

Intravenous administration of indocyanine green

ICG washout kinetics assessment
LiMON, Pulsion Medical SystemsDEVICE

Application of near infrared light

Pulse oximeter monitor
Gadolinium (Gadovist, Bayer, Germany)OTHER

Injection of gadolinium

Gadolinium washout kinetics assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients over 18 years old
  • diagnosed with meningitis in the examination of cerebrospinal fluid

You may not qualify if:

  • allergic to any of the contrast agents
  • a lack of consent to the test
  • liver failure and kidney failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University in Bialystok

Bialystok, 15-089, Poland

Location

Related Publications (2)

  • 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.

    PMID: 21964696RESULT

  • 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.

    PMID: 24110368RESULT

MeSH Terms

Interventions

Gadoliniumgadobutrol

Intervention Hierarchy (Ancestors)

Lanthanoid Series ElementsMetals, Rare EarthElementsInorganic ChemicalsMetals

Study Officials

  • Adam Liebert, Prof.

    Nalecz Institute of Biocybernetics and Biomedical Engineering Polish Academy of Science

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2016

First Posted

September 16, 2016

Study Start

August 1, 2015

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

October 18, 2018

Record last verified: 2018-10

Locations

PL(1)