Evolution 2
Research type
Research Study
Full title
Diagnostic Accuracy Study for OWL-EVO1 as a Lung Cancer EVOC® Probe
IRAS ID
1007323
Contact name
Alice Michael
Contact email
Sponsor organisation
Owlstone Medical Limited
Eudract number
2020-004433-20
Research summary
Despite decades of research, lung cancer has one of the lowest survival rates of all cancers. We hope that this trial will contribute towards a breath-based screening programme for lung cancer, which will lead to earlier detection, and higher survival rates. Recent research has shown that cells inside the body produce substances that end up in the lungs and are breathed out, or ‘exhaled’. These studies have shown that those substances may be different if someone is suffering from particular diseases, including cancer. Research has also shown that if a certain product (“probe”) is administered, it may be processed differently in your body if you are healthy, compared to if you have a disease. In this study we would like to see if we can distinguish between people with and without lung cancer by collecting and analysing their breath after having received an intravenous infusion of probe D5-ethyl- ßD-glucuronide (OWL-EVO1). Ethyl glucuronide is a substance that is already naturally produced in your body in much larger amounts if you consume alcohol. For this study the ethyl molecule has been labelled (which is why it’s called D5-ethyl), which means a marker has been attached to it, allowing it to be easily recognized on your breath. This label is not radioactive, and labelling is a harmless approach commonly used in research. When the probe is broken down in your body you will partly exhale it as a very small amount of alcohol. The other part of the molecule (glucuronic acid) will be removed from your blood by your kidneys. The amount of alcohol that is expected to be released in your blood will be less than when you would drink 1ml of wine. Subjects aged between 45-85, who have had a CT as part of clinical care, showing either the presence of absence of lung cancer may be eligible to take part in the study. The study will be run at NHS sites and will involve 1 dose of OWL-EVO1 and multiple breath samples (that will last between 5-15 mins each).
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
23/EE/0066
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion