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TSPO PET as a Measure of Post-stroke Brain Inflammation: a Natural History Cohort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662750
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Biogen
Invicro
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

DESIGN: exploratory, prospective, natural history, imaging cohort study

BACKGROUND: Stroke causes a strong inflammatory response in the brain which is thought to contribute to permanent brain damage in stroke patients. To develop new therapies targeting inflammation we need to better understand how inflammation affects the injured brain tissue and how it relates to neurological deficits that directly affect the patients' quality of life.

AIMS: To track the extent and location of inflammation in the brain after stroke over a period of 90 days. The study will explore whether the most inflamed areas in the brain undergo the most damage after stroke and correspond to the cognitive and neurological deficits experienced by stroke patients.

METHODS: The study involves an initial screening visit and 2 study imaging visits at days 15 and 90 after the stroke episode. Patients will undergo:

  1. Two 90-minute brain imaging sessions using Positron Emission Tomography (PET) (involves injection of safe radiotracers which attach to brain immune cell markers TSPOs and light up the inflamed areas in the brain),
  2. Two 45-90 minute Magnetic Resonance Imaging (MRI) scanning sessions (include administration of safe chemical contrast agent Gadolinium),
  3. Physical and neurological examinations (vital signs, assessments of mobility and cognitive functioning),
  4. Blood testing (routine measurements, blood inflammation markers, and genetic testing for TSPO marker).

Venous cannula will be inserted into the forearm for the duration of the scans.

POPULATION: 15- 25 patients (recruitment will cease once 15 patients have completed the study)

ELIGIBILITY: Male and female stroke patients, aged 18-85, with a recent (within last 10 days) ischemic stroke of moderate severity, able and willing to provide informed consent

LOCATION: Patients will be recruited at the Charing Cross Hospital, Imperial College Healthcare NHS Trust, and study scans will be performed by Invicro Centre for Imaging Sciences, Hammersmith Hospital

DURATION: 18 months FUNDED BY: Biogen Idec Ltd


Condition or disease Intervention/treatment Phase
Stroke, Ischemic Inflammatory Response Stroke, Acute Diagnostic Test: Brain Imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Exploratory, prospective, natural history, imaging cohort study
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: TSPO PET as a Measure of Post-stroke Brain Inflammation: a Natural History Cohort
Actual Study Start Date : August 31, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Brain Imaging

    The study involves an initial screening visit and 2 study imaging visits at days 15 and 90 after the stroke episode.Patients will undergo:

    1. Two 90-minute brain imaging sessions using Positron Emission Tomography (PET) (involves injection of safe radiotracers which attach to brain immune cell markers TSPOs and light up the inflamed areas in the brain),
    2. Two 45-90 minute Magnetic Resonance Imaging (MRI) scanning sessions (include administration of safe chemical contrast agent Gadolinium),
    3. Physical and neurological examinations (vital signs, assessments of mobility and cognitive functioning),
    4. Blood testing (routine measurements, blood inflammation markers, and genetic testing for TSPO marker).

    Venous cannula will be inserted into the forearm for the duration of the scans.

    Other Names:
    • Magnetic Resonance Imaging (MRI)
    • Positron Emission Tomography (PET-CT)


Primary Outcome Measures :
  1. Changes in TSPO radiotracer uptake infarct area [ Time Frame: 15 & 90 days ]
    PET-derived measures of TSPO radiotracer uptake in the infarct and peri-infarct areas at day 15 and day 90 after a stroke

  2. Changes in TSPO radiotracer uptake distant area [ Time Frame: 15 & 90 days ]
    PET-derived measures of TSPO radiotracer uptake in ROIs distant from the infarct area (e.g. thalamus, hippocampi, amygdalae and midbrain) at day 15 and day 90 after a stroke


Secondary Outcome Measures :
  1. PET Correlation [ Time Frame: 15 & 90 days ]
    Correlation of PET-derived measures with clinical and imaging measures of stroke severity (stroke volume, size and NIHSS) and functional outcome (mRS Barthel index, MoCA, depression, ) at day 15 and day 90

  2. MRI Correlation [ Time Frame: 15 & 90 days ]
    Correlation of infarct volume and MRI measures of white matter tract injury determined from DTI MRI with measures of thalamic TSPO uptake (time-activity curve; measures of mean and max TSPO uptake on summed image sets fromTSPO PET

  3. Blood Inflammatory Markers [ Time Frame: 15 & 90 days ]
    Correlation of PET derived measures with inflammatory markers in the blood (e.g. cytokines)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations in accordance with all local and national regulations OR according to the local institutional review board's (IRB's)/ethics committee's (EC's) guidelines OR by another process compliant with applicable national laws and regulations and IRB/EC requirement
  2. Aged 18-85 years of age at the time of informed consent
  3. Clinical diagnosis of supratentorial acute ischemic stroke within the previous 10 days. Note: An acute brain CT or MRI scan must be available from the patient's history to assess eligibility for the study and be consistent with the diagnosis of acute ischemic stroke.
  4. Score of at least 5 points on the NIHSS at Screening.
  5. Subjects of childbearing potential (male and female) must be willing and able to practice effective contraception during the study and for 4 weeks after their Day 90 appointment.
  6. Negative serum/ urine pregnancy test on all females of childbearing potential within 2 days before each PET study.

Exclusion Criteria:

  1. Unable or unwilling to provide informed consent.
  2. Presence of acute intracranial hemorrhage on acute brain CT or MRI
  3. Inability to comply with study requirements (including implanted pacemaker).
  4. Subject has contraindications to undergoing MRI examination (including, but not limited to metal foreign bodies incompatible with MRI exposure, cardiac pacemakers, renal impairment that contraindicates gadolinium etc.) or PET scan.
  5. Subject has participated in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with radiation exposure that, when combined with the radiation exposure from the present study, would exceed 10 mSV in addition to the natural background radiation, in the previous 12 months.
  6. Other unspecified reasons that, in the opinion of the Investigator make the subject unsuitable for enrollment.
  7. Nursing or pregnant females or females planning to become pregnant during study participation.
  8. Claustrophobic, unable to hold head continuously still for 90 minutes, or unwilling to undergo PET or MRI imaging and related procedures required for this study.
  9. Genetic polymorphism consistent with low TSPO binding affinity (expected in 10% of the population).

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): NCT03662750


Contacts
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Contact: Kirsten Harvey 02033117296 kirsten.harvey@imperial.ac.uk

Locations
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United Kingdom
Imperial College London Recruiting
London, United Kingdom, W6 8RF
Contact: Kirsten Harvey    02033117296    kirsten.harvey@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Biogen
Invicro
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03662750    
Other Study ID Numbers: GBR-TYS-16-11060
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
TSPO
MRI
PET
Stroke
Brain inflammation
Additional relevant MeSH terms:
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Stroke
Encephalitis
Inflammation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes