CompletedPhase IIInterventional

The assessment of D5 Ethanol as a marker in exhaled breath to distinguish between people with and without lung cancer

Lung cancer is often diagnosed late, which makes it harder to treat effectively. This UK clinical trial is testing a new breath test that could help doctors detect lung cancer much earlier. When our bodies break down substances, tiny chemical markers travel through the blood and leave the body when we breathe out. In this study, people aged 45 to 85 who have recently had a chest CT scan will receive a single, safe dose of a liquid marker through a small drip in the arm. As the body naturally clears this marker, it releases a harmless trace amount of alcohol into the breath—much less than a single drop of wine. By analysing breath samples collected through a mask, researchers hope to see clear differences between people with lung cancer and those without, paving the way for easier screening in the NHS.

At a glance

Status

Completed

Phase

Phase II

Sponsor

Owlstone Medical Limited

Enrolment target

350

Start

01 Sep 2023

Estimated completion

31 May 2025

Lung cancer

What is this study about?

Lung cancer is one of the most common cancers in the UK, but finding it early can be difficult because symptoms often do not appear right away. When cancer is caught in its earliest stages, treatments are far more likely to be successful. Because of this, doctors and scientists are searching for kinder, simpler ways to screen for lung cancer before it has a chance to grow or spread.

This trial investigates a promising new approach: using exhaled breath to check for cancer. Every time we breathe out, our breath carries microscopic chemical clues produced by our cells. Healthy cells and cancer cells process nutrients and chemicals differently. By checking these chemical patterns, researchers believe they can detect the subtle warning signs of lung cancer without needing invasive procedures.

To help reveal these signs, participants are given a special testing liquid called OWL-EVO1 through a small tube in their arm. This substance breaks down safely in the body and produces a tiny, harmless marker that travels out through the lungs. By comparing breath samples from people with lung cancer to samples from people without it, the research team aims to see if this breath test can reliably tell them apart.

Key takeaways

Tests whether a new, simple breath test can help detect lung cancer earlier.
Open to adults aged 45 to 85 who have had a chest CT scan.
Involves a single 4-to-5-hour hospital visit and one short follow-up phone call.
Uses a safe, non-radioactive marker given through a small arm vein.
Completely voluntary, with travel expenses reimbursed and no impact on your routine NHS care.

Who may be eligible?

You may be eligible to join this trial if you are between 45 and 85 years old and have recently had a chest CT scan as part of your normal medical care. The scan could have shown lung cancer, or it could have shown healthy lungs; researchers need both groups to compare the results. You must also be able to breathe comfortably into a mouthpiece or face mask for short periods.

You will not be able to take part if you struggle with claustrophobia or have trouble breathing into a mask. You are also not eligible if you have had major lung surgery in the past, or if you are currently pregnant, breastfeeding, or participating in another trial testing a new medicine.

If doctors are currently investigating you for another unexplained cancer that has not yet been confirmed, you will need to wait. However, if you already have a known, confirmed diagnosis of another cancer, or if you are attending regular screening programmes (such as bowel, breast, or prostate screening), you can still take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am between 45 and 85 years of age.
I have recently had a chest CT scan.
I can comfortably breathe into a face mask or mouthpiece for up to 15 minutes.
I have not had major lung surgery in the past.
I am not pregnant or breastfeeding.
I have not taken an experimental drug in another clinical trial within the past 28 days.

Answer every question to see your result.

What does participation involve?

Taking part involves one visit to an NHS hospital clinic, lasting approximately 4 to 5 hours. During your visit, a trained healthcare professional will take a routine blood sample and place a small, soft plastic tube (cannula) into a vein in your arm. You will receive a single dose of the liquid marker through this tube. Over the next few hours, you will be asked to breathe normally into a mask or mouthpiece for periods of 5 to 15 minutes at a time. The clinic team will keep a close eye on you for about 3 hours after your dose to make sure you remain comfortable. After you go home, a member of the research team will call you 3 to 5 days later to check how you are feeling. Your travel expenses and time will be reimbursed.

Potential risks and benefits

Taking part in this study will not directly improve your own health or change your current medical care, but your help could lead to a painless breath test that saves lives in the future. The risks are very low. Having a cannula put in may cause minor, temporary bruising or soreness at the needle site. The marker substance is safe, non-radioactive, and produces less alcohol in your body than a tiny fraction of a drop of wine, so you will not feel intoxicated or unwell. Some people may find breathing into a mask slightly tiring or awkward, but it will not restrict your natural breathing. Taking part is entirely voluntary, and you are free to leave the study at any time without it affecting your NHS care.

Locations (5)

Royal Papworth Hospital (papworth Everard)
City only
Cambridge, England
Imperial College Healthcare NHS Trust
City only
London, England
Norfolk and Norwich University Hospitals NHS Foundation Trust
City only
Norwich, England
Wythenshawe Hospital
Approximate
Manchester, England
Glenfield Hospital
Approximate
Leicester, England

Common questions

Will the marker make me feel drunk?

No. The substance produces an amount of alcohol smaller than a single drop of wine, which is far too tiny to cause any alcohol-like effects or make you feel drunk.

Is the marker substance radioactive?

No. The marker is labelled with a completely harmless, non-radioactive element so the laboratory equipment can easily spot it on your breath.

Will this study delay my normal cancer scans or treatment?

No. The study visit is arranged at a convenient time and will not interrupt or delay your regular NHS appointments or care plan.

Does the breath test hurt?

Not at all. You simply breathe as you normally would through a soft mask or mouthpiece for 5 to 15 minutes at a time.

Will my travel costs be covered?

Yes. The trial team will compensate you for your travel expenses and the time you spend taking part in the hospital visit.

How to find out more

Louise Harlow

chloe.bartlett@owlstone.co.uk +44 (0)1223 428200 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.