Imaging cerebral neuroinflammation in CVD (IN-CVD)

• Research type

  Research Study

• Full title

  Imaging cerebral neuroinflammation in acute and chronic cerebrovascular disease: a predictor of outcome and biomarker for guiding treatment (IN-CVD)

• IRAS ID

  151852

• Contact name

  Karl Herholz

• Contact email

  karl.herholz@manchester.ac.uk

• Sponsor organisation

  The Christie NHS Foundation Trust

• Eudract number

  2014-000591-26

• Duration of Study in the UK

  3 years, 11 months, 31 days

• Research summary

  Acute stroke is part of the spectrum of cerebrovascular disease (CVD). Inflammation occurs around the damaged tissue and blood vessels which can increase the severity of stroke. Microglial cells are an important type of cell that have several functions in supporting nerve cells, including regulating the inflammatory response in the brain. The brain damage and inflammation means that there is an increase in translocator protein (TSPO) due to the responding microglial cells. This study aims to evaluate the association between microglia activation and the outcome in stroke patients. PET (positron emission tomography) can be used to image the inflammation in the brain. This is done by using an imaging agent that binds to the TSPO. [18F]GE-180 is a newly developed imaging agent with good selectivity for TSPO.
  The first year of the trial (phase 1) will be dedicated to assessing the technical feasibility, and comparing the new imaging agent ([18F]GE-180) with an existing agent ([11C]-(R)-PK11195). It is hoped that the agents are technically comparable. [11C]-(R)-PK11195 is unable to be used in routine clinics due to the reduced half-life (20 minutes), which is too short to allow routine clinical procedures but the new agent has a half-life of 110 minutes, which would be able to be used in clinics.
  Assuming phase 1 of the study is successful the study can progress to phase 2 (on approval by the IDMC). In phase 2 of the study, patients will only have a PET scan using the new agent imaging. Data will be collected on a further 40 patients, ensuring that by the end of the trial there will be data on 50 stroke patients. The data from the entire study will be used to identify the microglial activation and determine if a correlation between with clinical outcome and inflammation can be demonstrated

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  15/NW/0032

• Date of REC Opinion

  3 Mar 2015

• REC opinion

  Further Information Favourable Opinion