Clinical Trials

Technologies and novel techniques for diagnosis and treatment developed with the Institute and in collaboration with industrial partners are continuously entering clinical trials. Our researchers are not only involved in the discovery, prototyping and development of new technologies, but also receive training and work with clinical colleagues to understand the human factors involved in their clinical deployment and drive their adoption. Working with the University of Oxford registered clinical trials unit, our portfolio and expertise ranges from diagnostic and predictive techniques involving Big Data, wearable devices and mobile phones, to Class II and Class III medical devices for diagnosis and therapy and combination products involving both a device and a drug.

Solid tumours represent a major barrier to drug delivery, particularly for next-generation macromolecular therapeutics such as immuno-oncology antibodies and oncolytic viruses. The CEeDD clinical trial aims to test for the first time in patients whether a technology initially developed within the IBME and licensed and clinically translated by University spin-out OxSonics Therapeutics can help increase the delivery, penetration and efficacy of standard-of-care drug treatments for metastatic colorectal cancer (mCRC) in the liver. The novel treatment consists of an infusion of proprietary solid gas-stabilizing cavitation nuclei (the SonoTran particles) alongside the standard combination of FOLFIRI chemothery and Cetuximab antibodies in KRAS-wildtype mCRC patients, following which the liver is targeted using a novel handheld ultrasound device (the SonoTran system). Under the influence of targeted focused ultrasound, the circulating SonoTran particles are activated to enhance transport and penetration of the therapeutic agents into targeted tumours visible on conventional ultrasound imaging. The drug delivery process is monitored in real time using Passive Acoustic Mapping, an innovative technique also developed within the IBME.

The key aims of hte CEeDD study is to demonstrate safety of the SonoTran intervention, to establish in patients whether this novel technique is capable of enhancing drug delivery and distribution in solid tumours, and to obtain an early readout of increased efficacy that these enhancements may be able to offer patients. The trial is supported by the National Institute for Health Research under award NIHR201655, sponsored by the University of Oxford, and managed by the Department of Oncology’s clinical trials office (OCTO).

Cavitation-Enhanced Drug Delivery (CEeDD)

Patients routinely undergo deep brain stimulation (DBS) for treatment of symptoms related to neurodegenerative conditions, most commonly Parkinson’s disease. In the Investigator’s experience, and published evidence shows, that stimulation has effects on the autonomic nervous system. In patients undergoing therapeutic DBS for a particular subtype of Parkinsonism (Multiple System Atrophy), the effects on autonomic parameters such as blood pressure and bladder symptoms has been shown to be improved by the investigators (unpublished data). In this current study, the investigators plan to use a novel technique of adaptive DBS in order to provide stimulation dependent on patient physiological or positional factors. This is with the aim of making stimulation more responsive and patient-specific.

MotIoN aDaptive Deep Brain Stimulation for MSA (MINDS)

The CADET Pilot will investigate the safety and feasibility of deep brain stimulation (DBS) to treat children with Lennox-Gastaut syndrome using a novel DBS device (Picostim DyNeuMo-1).

Following a 30-day preoperative/baseline assessment phase, all children will have a neurosurgical procedure to implant the device. Implantation will be followed by a 30-day phase of no stimulation (the device is off / inactive) and then a six-month phase of active stimulation (the device is on / active)

Children's Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET-Pilot)

PULsE-AI for predicting arterial fibrillation using GP data

The “PULsE-AI” project is a screening tool that is implemented within Primary Care computer systems, which uses routinely-acquired data from GPs to predict the risk of future heart arrhythmia (atrial fibrillation, or AF).  One of the greatest risk factors for stroke is untreated AF, but it is very difficult to identify this condition without relatively invasive equipment.  This project, developed with Pfizer and Bristol-Myers Squibb, offers a step-change in our ability to screen patients for AF, without using anything other than the standard data that are recorded by GPs when one visits for a health check.  This work has been fast-tracked through Randomised Controlled Trials and subsequent “health economics” trials, and is now in the process of final implementation within GP computer systems ( ( Identifier: NCT04045639).

AI-Predicted Heart Arrythmia

MORPHEUS: Manipulating and Optimising Brain Rhythms for Enhancement of Sleep

The aim of this feasibility study is to investigate whether we can improve sleep quality in patients with deep brain stimulators by delivering targeted stimulation patterns during specific stages of sleep. We will examine the structure and quality of sleep as well as how alert patients are when they wake up, while also monitoring physiological markers such as heart rate and blood pressure. Upon awakening, we will ask the patients to provide their subjective opinion of their sleep and complete some simple tests to see how alert they are compared to baseline condition which would be either stimulation at the standard clinical setting or no stimulation. We hope that our study will open new ways of optimising sleep without the use of drugs, in patients who are implanted with depth electrodes. We also believe that our findings will broaden the understanding of how the activity of deep brain areas influences sleep and alertness Identifier: NCT05011773).

Brain Stimulation for Better Sleep

Prolonged preservation and assessment of kidneys for transplantation

Almost 5000 patients in the UK remain on the NHS waiting list for a kidney transplant because of a persistent shortage of suitable donor organs. Unlike conventional cold storage, normothermic machine perfusion places the organ in an environment that closely resembles that of the body: blood, oxygen and nutrition are provided at normal body temperature (37 C), to allow the kidney to recover from the process of donation, avoiding the progressive injury that occurs if the organ is stored on ice. Also, because the kidney is functioning during preservation, it is possible to test its viability before the transplant. In partnership with OrganOx Ltd, we have built a normothermic kidney perfusion machine capable of 24 hours of preservation are now ready to test this new technology in 36 patients undergoing kidney transplants at the Oxford Transplant Centre. This trial is primarily designed to test the safety and feasibility of the new technology. It will also provide some evidence regarding effectiveness, to enable a larger randomised trial that will test efficacy formally.

Normothermic Kidney Preservation for Transplantation