The VISION study
Research type
Research Study
Full title
The VISION Study: Vascular Inflammation Imaging Using Somatostatin Receptor Positron Emission Tomography
IRAS ID
142128
Contact name
James Rudd
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Research summary
Cardiovascular events such as heart attacks and stroke are caused when atherosclerotic plaques rupture, and are a leading cause of death worldwide. Vascular inflammation plays an important role in the pathogenesis of atherosclerosis and plaque rupture, but inflammation cannot be detected by conventional imaging modalities such as xray angiography. 18F-FDG PET is a nuclear imaging technique that can be used to track vascular inflammation due to atherosclerosis, and is the current gold standard in this field. However, there are some disadvantages to 18F-FDG. 18F-FDG is taken up by all metabolically active cells, and high background uptake can obscure interpretation of the vascular signal. This is particularly problematic when imaging coronary arteries.
The VISION study will evaluate 68Ga-DOTANOC PET for imaging arterial wall inflammation in atherosclerosis. 68Ga-DOTANOC is a somatostatin receptor ligand, currently used in neuroendocrine tumour imaging, which may have certain advantages over 18F-FDG PET. 68Ga-DOTANOC targets subtypes of somatostatin receptors that are over-expressed in activated macrophages, and therefore may be a more specific marker of inflammation than 18F-FDG. Additionally, as 68Ga-DOTANOC is not taken up by the myocardium, it may also be better than 18F-FDG for coronary artery imaging.
VISION is a single centre, prospective observational pilot study. We aim to recruit 50 participants with carotid and/ or coronary artery disease for PET/CT imaging with both 68Ga-DOTANOC and 18F-FDG-PET. We expect ≈15 participants to undergo carotid endarterectomy as part of clinical management. The primary study outcome will be comparison of carotid artery 68Ga-DOTANOC signal to macrophage density, assessed by CD68 immunohistochemical staining of carotid endarterectomy samples.
This study aims to investigate the role of inflammation in atherosclerosis using 68Ga-DOTANOC PET, and to validate 68Ga-DOTANOC PET for detection and quantification of vascular inflammation. It will also help determine whether 68Ga-DOTANOC is superior to 18F-FDG for this purpose.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
14/EE/0019
Date of REC Opinion
27 Feb 2014
REC opinion
Further Information Favourable Opinion