Breath test could revolutionize lung cancer detection
NCT ID NCT06193239
First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This study is testing a new breath test called OWL-EVO1 to see if it can accurately tell the difference between people who have lung cancer and those who do not. The test involves breathing into a device after taking a special probe. Researchers are enrolling adults aged 45-85 who have had a recent chest CT scan. If the test works well, it could become a simple, non-invasive tool for lung cancer screening.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OWL-EVO1 Breath Biopsy Test (D5-ethyl-βD-glucuronide EVOC probe)
- What this could lead to
- If successful, this breath test could offer a non-invasive, quick way to help detect lung cancer earlier, potentially improving outcomes.
- What could go wrong
- This is a Phase 2a study with 187 participants, so results are preliminary. The test may not prove accurate enough for widespread use, and breath sampling can be technically challenging.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
187 people
The number who actually took part.
- Started
-
Oct 2023
- Finished
-
May 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
45 to 85 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged 45-85 years. * Ability to provide informed consent. * BMI 16 - \<40. * Receiving a CT including the thoracic region, within the last 6 months. Exclusion Criteria: 1. (Anticipated) inability to complete the breath sampling procedure (e.g., inability to maintain adequate ventilation unaided or claustrophobia). 2. Potential subjects who in the opinion of the investigator lack mental capacity. 3. Received an investigational medical product in the context of a Clinical Trial (CTIMP) during the 28 days prior to administration of the (first) probe, or within 5 times the half-life of the investigational medicinal product previously received, whichever is longer.\* 4. Individuals under diagnostic investigation for a potential malignancy other than lung cancer that has not yet reached a conclusive diagnosis\*\*. 5. Individuals with an inconclusive lung abnormality (indeterminate pulmonary nodule) on CT-scan requiring CT-based monitoring rather than biopsy and/or treatment. 6. Documented history of pulmonary surgery or endobronchial interventional procedures other than biopsy, lavage, or bronchial brushings. These include surgical resection, Video Assisted Thoracic Surgery (VATS), bronchial thermoplasty and coiling, airway stenting or other interventional bronchoscopic procedures. 7. Pregnant or breastfeeding women and women of child-bearing potential not using adequate contraceptive methods (Subjects must agree to use contraception for 2 months post last dose). 8. Individuals under investigation for suspicion of lung cancer who are unlikely to receive a definitive tissue diagnosis of lung cancer prior to treatment (e.g. stereotactic ablative radiotherapy without tissue confirmation). * Note: In the case that the participant has taken part in a study with an investigational medicinal product please contact the Owlstone medical monitor for advice. \*\*Note: Individuals with a confirmed cancer diagnosis ARE eligible (such as a diagnosis of prostate cancer now undergoing hormone therapy). Individual with a previous history of cancer other than lung cancer, including those under active surveillance, ARE eligible. Individuals scheduled to attend a cancer screening program; prostate, breast, lung, colon, ARE eligible.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Lung cancer are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Barts Health NHS Trust
London, London, E1 1FR, United Kingdom
-
Department of Pulmonology, University of Debrecen
Debrecen, Debrecen, H-4032, Hungary
-
Glenfield Hospital
Leicester, Leicestershire, LE3 9QP, United Kingdom
-
Imperial Centre for Translational and Experimental Medicine, Imperial College
London, London, W12 0HS, United Kingdom
-
National Koranyi Institute for Pulmonology
Budapest, Budapest, H-1121, Hungary
-
Quadram Institute
Norwich, Norfolk, NR4 7UQ, United Kingdom
-
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0AY, United Kingdom
-
Thomayer Hospital
Prague, Prague, 140 59, Czechia
-
Wythenshawe Hospital
Manchester, Greater Manchester, M23 9LT, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Surgeons could freeze lung tumors from miles away using 5G robots
- Can AI make lung cancer scans easier to read?
- Two-Drug combo targets Treatment-Resistant lung cancer
- Can an Anti-Fibrotic drug shield lungs from radiation after immunotherapy?
- App aims to catch a hidden radiotherapy side effect
- Which nerve block wins for lung surgery pain?