Clinical trial at Royal Papworth Hospital tests Owlstone Medical technology for early diagnosis of lung cancer
A clinical trial to test if ethanol detected in exhaled breath can be used for the early diagnosis of lung cancer has begun at Royal Papworth Hospital in Cambridge.
Utilising technology from Cambridge Science Park-based Owlstone Medical, the EVOLUTION trial aims to recruit 25 patients who definitely have lung cancer and 25 healthy volunteers who do not.
The volunteers are given a liquid solution containing a metabolic probe that is administered intravenously and travels around the body. When it reacts with a lung tumour, it causes the release of ethanol.
After a set amount of time, the volunteers are asked to breathe at regular intervals into a mask, which collects the ethanol for laboratory analysis. The mask and the eVOC probe (Exogenous Volatile Organic Compound) were developed by Owlstone, which has been involved in multiple trials with its Breath Biopsy technology.
Prof Robert Rintoul, lead clinician for cancer at Royal Papworth Hospital, said: “We know from previous work that there is an enzyme around the tumour cells called glucuronidase. The glucuronidase in the lung cancer processes the eVOC probe releasing the ethanol which can be detected in breath.
“If you have got lung cancer we should see an ethanol signal in the breath; if you have not got lung cancer then there is nothing to process and so there should not be any ethanol signal present.
“At the moment it requires a lot of equipment, an intravenous injection of the probe and patients have to breath into the mask several times over a few hours.
“We hope that if this ‘proof of principle’ trial can demonstrate a difference in ethanol levels between people who do and do not have lung cancer, we can then simplify the process.
“Ideally, we would like to develop a probe that can be inhaled rather than injected and a much simpler breath collection device. If so, we might be able to use it in the GP surgery or even at home as a lung cancer screening tool for at-risk patients.
“This is a very exciting beginning. It opens a new, innovative avenue for detecting lung cancer. If we can develop this further and roll this out it will save lives.”
Billy Boyle, co-founder and CEO at Owlstone Medical, said: “Breath Biopsy has proven to be extremely effective at detecting VOCs in the breath, and we are pleased to be working with Royal Papworth Hospital as we look to apply it towards the incredibly important area of detecting early-stage lung cancer in patients.”
About 48,000 people are diagnosed in the UK each year with lung cancer, making it the third most common cancer in the country. It is also the biggest cancer killer, with only 16 per cent of lung cancer patients in the UK surviving five or more years.
The key reason for this is that people do not develop symptoms, such as a persistent cough, coughing up blood, regular chest infections or weight loss, until the disease is advanced and harder to treat or cure.
“Just a quarter of lung cancers are detected at an early stage when treatment is more likely to be successful,” explained Prof Rintoul. “Many of these cases are picked up by chance because they had X-rays or scans for other reasons.
“A decade ago lung cancer survival for five or more years was seven to eight per cent. By 2025, it is hoped that 25 per cent of all people diagnosed with lung cancer survive.
“To do this, we need to do more to find lung cancer at the earliest stages. Through driving early detection up and up, survival rates should follow. Possible screening tools as CT scanning and this Breath Biopsy equipment is therefore vital.”
Wendy Tait, 70, from Melbourn, was one of the first patients recruited to the trial.
Her lung cancer was found during a hospital CT scan on her back ahead of spinal surgery.
She went to her GP and was placed on a cancer pathway.
“My grandmother, mother and father all died of lung cancer,” she said. “Although I stopped smoking 16 years ago I was a heavy smoker for a number of years so I always knew I would be at risk.
“I am very lucky that my cancer is early stage and treatable with surgery. My parents were not so lucky – they both died a few months after being diagnosed.
“Research like this is very important. So many people would benefit from this early detection test which is amazing. It is why I was so keen to sign up to research and would encourage all patients to do the same.”