Research and development services and related consultancy services

Tender description

The Department of Radiology of the University of Cambridge strive to be an internationally competitive department undertaking innovative research in medical imaging. We have a team of dedicated academic radiologists working with imaging scientists with an active doctoral and post-doctoral research programme. We have extensive facilities across Addenbrooke’s Hospital, including one 3T MRI, five 1.5T MRI machines, PET CT and four CT machines on which we undertake research. There is a large ultrasound department and a nuclear medicine facility. We are part of the Wolfson Brain Imaging Centre (WBIC) which undertakes both neuro and body imaging on the 7T, two 3T MR machines and a PET MR machine. We are developing fumarate as a new agent to use in Radiology to perform metabolism imaging. We are currently using pyruvate in physiological human studies for metabolism imaging and are looking at progressing fumarate to first-in-man studies. We are developing fumarate as a new agent to use in Radiology to perform metabolism imaging. We are currently using pyruvate in physiological human studies for metabolism imaging and are looking at progressing fumarate to first-in-man studies. Magnetic resonance spectroscopy (MRS) is capable of non-invasive imaging of biochemical reactions in vivo by allowing both substrates and products to be detected. However, its lack of sensitivity and relatively low temporal resolution results in images that, at best, can only be produced at relatively low spatial resolution and generally prevents real-time imaging in humans, producing only a static picture of tissue metabolism. Introduction of a 13C-labelled substrate (13C is a stable, non-radioactive form of carbon, which is MR-active) and detection of the 13C-labelled metabolites formed from it using 13C-MRS, can provide information on metabolic flux. As 13C-MRS is significantly less sensitive than proton (1H) MRS, the introduction of dissolution DNP, where hyperpolarization of the 13C nucleus enhances its sensitivity to detection by more than 10 000-fold, has allowed dynamic imaging of cellular metabolic fluxes in vivo in the absence of any background signal. We have shown in preclinical studies that we can use hyperpolarized [1,4-13C2] fumarate to distinguish between inflammation and necrosis in the kidney. The utility of fumarate for detecting cell death has been demonstrated in a murine lymphoma model and in a murine xenograft model of breast cancer. We want to progress this work to first in man studies where we plan to inject a solution of sodium fumarate, which will have to be dissolved in 1,8 % DMSO and mixed with EPA (Electron Paramagnetic Agent) to allow hyperpolarisation prior to injection to patient. We have some animal data and some toxicology data about initial toxicology testing for this molecule in animals (non-GLP) and need to perform a formal Pre-Clinical Safety Package by the Intravenous Route to Support FTIH Studies. Requirements details are included in the specification compliance table.