N/A
N=3
TSPO PET as a Measure of Post-stroke Brain Inflammation: a Natural History Cohort
Stroke, Ischemic · Inflammatory Response · Stroke, Acute
Bottom Line
View on ClinicalTrials.gov: NCT03662750 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Changes in TSPO Radiotracer Uptake Infarct Area — 1.54 g/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brain Imaging (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in TSPO Radiotracer Uptake Infarct Area |
1.54 | — |
| PRIMARY Changes in TSPO Radiotracer Uptake Distant Area |
0.89 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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
- Aged 18-85 years of age at the time of informed consent
- 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.
- Score of at least 5 points on the NIHSS at Screening.
- 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.
- Negative serum/ urine pregnancy test on all females of childbearing potential within 2 days before each PET study.
Exclusion Criteria
- Unable or unwilling to provide informed consent.
- Presence of acute intracranial hemorrhage on acute brain CT or MRI
- Inability to comply with study requirements (including implanted pacemaker).
- 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.
- 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.
- Other unspecified reasons that, in the opinion of the Investigator make the subject unsuitable for enrollment.
- Nursing or pregnant females or females planning to become pregnant during study participation.
- 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.
- Genetic polymorphism consistent with low TSPO binding affinity (expected in 10% of the population).
Data sourced from ClinicalTrials.gov (NCT03662750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.