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TSPO PET as a Measure of Post-stroke Brain Inflammation: a Natural History Cohort
NA trial testing Brain Imaging in Stroke, Ischemic in 3 participants. Completed in 31 December 2019.
| Lead sponsor | Imperial College London |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 3 |
| Start date | 31 August 2017 |
| Primary completion | 31 December 2019 |
| Estimated completion | 31 December 2019 |
| Sites | 1 location across United Kingdom |
Imperial College London
Adults 18 to 85, any sex, with Stroke, Ischemic or Inflammatory Response. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
PET-derived measures of TSPO radiotracer uptake in the infarct and peri-infarct areas at day 90 after a stroke (compared with Day 15)
| Group | Value | 95% CI |
|---|---|---|
| Acute Stroke Cohort | 1.54 | ± 0.39 |
PET-derived measures of TSPO radiotracer uptake in ROIs distant from the infarct area (e.g. thalamus, hippocampi, amygdalae and midbrain) at day 90 after a stroke (compared with Day 15)
| Group | Value | 95% CI |
|---|---|---|
| Acute Stroke Cohort | 0.89 | ± 0.04 |
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
2 peer-reviewed publications reference this trial (live from Europe PMC):
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