Blood-Brain Barrier PermeabilityNM-BBBPNCT02902588
Blood-brain Barrier Permeability Study in Adults With Meningitis
A study testing ICG-PULSION, LiMON, Pulsion Medical Systems and Gadolinium (Gadovist, Bayer, Germany) in people with Blood-Brain Barrier Permeability, run by Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood-Brain Barrier Permeability
- What is being tested?
- ICG-PULSION, LiMON, Pulsion Medical Systems and Gadolinium (Gadovist, Bayer, Germany)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2015to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients over 18 years old
- diagnosed with meningitis in the examination of cerebrospinal fluid
Who cannot join
- allergic to any of the contrast agents
- a lack of consent to the test
- liver failure and kidney failure
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- 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
- Blood-Brain Barrier Permeability
- Being tested
- ICG-PULSION, LiMON, Pulsion Medical Systems, Gadolinium (Gadovist, Bayer, Germany)
- Keywords
- Blood-Brain Barrier, Magnetic Resonance Imaging, Spectroscopy, Near-Infrared, Indocyanine green
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG-PULSIONOther
Intravenous administration of indocyanine green
LiMON, Pulsion Medical SystemsDevice
Application of near infrared light
Gadolinium (Gadovist, Bayer, Germany)Other
Injection of gadolinium
| Study group | Role | What they receive |
|---|---|---|
| ICG washout kinetics assessment | Experimental | Intravenous administration of 5-10 mg indocyanine green (ICG-PULSION), once per subject Receives: Other: ICG-PULSION |
| Pulse oximeter monitor | Other | Monitoring of a person's oxygen saturation (SO2), peripheral oxygen saturation Receives: 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 Receives: Other: Gadolinium (Gadovist, Bayer, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start1 Aug 2015
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Why it stopped: The tests have been completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Blood-Brain Barrier PermeabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Liebert, Prof., Study chair, Nalecz Institute of Biocybernetics and Biomedical Engineering Polish Academy of Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902588
- Sponsor's protocol ID
- BBBP-1PW5
- Acronym
- NM-BBBP
- Status last verified
- Oct 2018
- First submitted
- 23 Aug 2016
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21964696Liebert 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.
PubMed 24110368
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02902588
- Acronym / sponsor ID
- NM-BBBP / BBBP-1PW5
- Conditions
- Blood-Brain Barrier Permeability
- Keywords
- Blood-Brain Barrier, Magnetic Resonance Imaging, Spectroscopy, Near-Infrared, Indocyanine green
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The tests have been completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of SciencesUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICG washout kinetics assessment | Experimental | Other: ICG-PULSIONIntravenous administration of 5-10 mg indocyanine green (ICG-PULSION), once per subject |
| Pulse oximeter monitor | Other | Device: LiMON, Pulsion Medical SystemsMonitoring of a person's oxygen saturation (SO2), peripheral oxygen saturation |
| Gadolinium washout kinetics assessment | Experimental | Other: Gadolinium (Gadovist, Bayer, Germany)20 mL of gadolinium (Gadovist, Bayer, Germany) injection at 5 mL/s, once per subject |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients over 18 years old
- diagnosed with meningitis in the examination of cerebrospinal fluid
Key exclusion criteria (3 listed)
- allergic to any of the contrast agents
- a lack of consent to the test
- liver failure and kidney failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICG-PULSIONIntravenous administration of indocyanine green | Other | ICG washout kinetics assessment |
| LiMON, Pulsion Medical SystemsApplication of near infrared light | Device | Pulse oximeter monitor |
| Gadolinium (Gadovist, Bayer, Germany)Injection of gadolinium | Other | Gadolinium washout kinetics assessment |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: The tests have been completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Results publication: PubMed 21964696Ergin 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.
- Results publication: PubMed 24110368Liebert 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Liebert, Prof. study chair
Nalecz Institute of Biocybernetics and Biomedical Engineering Polish Academy of Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG-PULSION, LiMON, Pulsion Medical Systems and Gadolinium (Gadovist, Bayer, Germany) in people with Blood-Brain Barrier Permeability, run by Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The tests have been completed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between blood brain barrier permeability assessment with use of near infrared spectroscopy and magnetic resonance imaging (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02902588, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.