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Enhancing drug delivery using focused ultrasound in patients with pancreatic cancer

Type of opportunity: 

Reviewing trial documents, including the protocol, patient information sheet and consent form, to optimise an early phase trial for patients with metastatic pancreatic cancer. This can be done from your own home based anywhere in the UK.

The deadline for returning your comments is Friday 11th October 2019.

About the study: 

Current treatment for patients with pancreatic cancer, for whom surgery is not an option, is to receive chemotherapy. However, drug delivery is limited by a dense protein structure in the tumour. This acts as a physical barrier, to prevent drugs reaching the pancreatic cancer cells. We would therefore like to investigate ways of improving how drugs reach the cancer cells. Previous work has shown that gentle heating of tumours causes changes in the blood vessels, to allow more drug to enter into the tumour. Ultrasound is a non-invasive, safe and low cost way of imaging tumours and focused ultrasound can be used to generate heat in localised areas approximately the size of a grain of rice. Chemotherapy drugs such as doxorubicin can be coated with a heat-sensitive layer, so that the active drug is only released when a specific temperature is reached, and at the specific location which has been heated.

This study will combine focused ultrasound to generate heat, and a heat-sensitive chemotherapy drug (ThermoDox), delivered into the bloodstream. We will compare this to standard delivery of chemotherapy – the drug given into the blood without the addition of ultrasound. A small sample of treated pancreas tissue will then be taken for analysis. This will help determine whether the novel approach to delivering chemotherapy can improve the amount of drug delivered to pancreas tumours, and if the drug can travel further into the tumour. We hope this will result in an improved response to chemotherapy for patients.

Who is conducting the research? 

Researchers at the University of Oxford, including engineers from the Institute of Biomedical Engineering (Lead Scientific Investigator Prof Constantin Coussios, Dr Michael Gray), Oncology doctors (Chief Clinical Investigator Prof Mark Middleton, Dr Laura Spiers and Dr Shivan Sivakumar) and Radiologists (Prof Feng Wu and Dr Paul Lyon)

When will this trial be recruiting/taking place?

The researchers are aiming for the trial to open to recruit patients in January 2020.

Who can take up this opportunity? 

Anyone with experience of pancreatic cancer (patients, family, carers)

Who has reviewed the study? 

The study is being sponsored by the University of Oxford, having been reviewed by the Clinical Trials Development Group. It will be submitted for ethical review.

How will the study benefit people affected by pancreatic cancer?

This is a “proof of concept” early phase study to see if more drug can be delivered safely into the tumour; we do not know if this will happen (hence the need for the trial) and whether this will translate into an effect on tumour size. Therefore patients in the trial may not receive a direct clinic benefit. However, in previous work using the same drug and ultrasound technology in patients with tumours predominantly in the liver, some patients had tumours that became smaller and less active.

As part of the trial, participants will have additional scans beyond those offered in standard of care (PET-CT scan and ultrasound imaging) which some patients may find helpful. In addition, the treatment aims to take place during a window of waiting (setting up chemotherapy), which can typically be a period of anxiety for patients. Patients in the trial would have the trial assessments and intervention during this window, which will hopefully help them feel supported during this time. The trial does not replace the current chemotherapy regimens. Patients in the trial would be receiving an additional dose of chemotherapy (compared to the current standard regimens) which we would not expect to impact upon their subsequent chemotherapy choices.

If the trial is successful, it would be expanded to a larger trial, aiming to offer the technology to more patients, and offering a range of therapeutic options (chemotherapy, immunotherapy or targeted molecular agents). Funding bodies for this have already been approached, but outcomes are dependant on this initial trial. Ultimately, we hope this would enable more effective treatments of pancreatic cancer.

What next/who to contact:

Please contact Dr Laura Spiers with any expressions of interest