PBR28-PET in Crohn's disease
Research type
Research Study
Full title
A Study to Evaluate Inflammation in Crohn's Disease Using Positron Emission Tomography
IRAS ID
215724
Contact name
Azeem Saleem
Contact email
Sponsor organisation
AbbVie
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
The Translocator Protein (TSPO) located within the cells such as macrophages reaches high levels of expression in inflammatory conditions. PBR28 is a chemical substance that binds to TSPO (a TSPO ligand). When radioactivity in the form of carbon-11 is tagged to PBR 28 ([11C]PBR28 - called a radioligand) and is administered, its uptake in the inflammatory body regions can be measured using positron emission tomography (PET). The uptake of PBR28 in the bowel of patients with Crohn's disease (CD), an inflammatory bowel condition is unknown, which we aim to look at in this study.
However, the radioligand that is taken up in the body also gets attached to cells that do not express TSPO (known as non-specific binding). In order to evaluate the specific binding ability of PBR28, we plan to do a TSPO blocking study by administering XBD173 (a TSPO targeting drug) to bind to TSPO and block binding of the PET ligand and measuring the radioligand uptake. Such a blocking study will help us to work out how much of a PET signal represents “specific binding” (of the radioligand to the target of interest), and how much represents “non-specific binding” (of the radioligand to many other structures which are not of interest).
This study will therefore aim to evaluate uptake of PBR28 and the specificity of such binding in the bowels of healthy volunteers and patients with CD. Up to 7 healthy volunteers and 7 subjects with CD will be evaluated in this study. The study is sponsored by AbbVie Inc. All subjects will have their scans done at Imanova Ltd, London. Subjects will be recruited by Hammersmith Medicines Research, London. Subjects will also be identified at two other Patient Identification Centres (PICs). We expect the study to last up to 18 months.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
16/WM/0496
Date of REC Opinion
6 Jan 2017
REC opinion
Further Information Favourable Opinion