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Breath test could revolutionize lung cancer detection

NCT ID NCT06193239

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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