Breath test for diagnosing lung cancer

Diagnostic Accuracy Study for OWL-EVO1 As a Lung Cancer EVOC® Probe

This study is trying out a new breath test to see if it can help tell the difference between people with lung cancer and those without it.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 45 Years to 85 Years
• Sex: All
• Sponsor: Owlstone Ltd (Industry-sponsored)
• Locations: 9 sites (Prague, Prague and 8 other locations)
• Trial ID: NCT06193239 on ClinicalTrials.gov

What this trial studies

The Evolution Phase 2a study evaluates the diagnostic accuracy of the OWL-EVO1 Probe Breath Biopsy Test, which aims to differentiate individuals with lung cancer from those in relevant contrast groups. This cross-sectional, case-control trial will involve administering the OWL-EVO1 probe intravenously to both lung cancer cases and controls, with breath samples collected over a specified period. The study seeks to optimize the test protocol to enhance tolerability and diagnostic accuracy while minimizing healthcare worker effort. Up to 150 lung cancer cases and 200 controls will be recruited across various sites in the UK and EU.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 45-85 who have undergone a CT scan of the thoracic region within the last 6 months.

Not a fit: Patients currently under diagnostic investigation for other malignancies or with inconclusive lung abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this test could provide a non-invasive and accurate method for diagnosing lung cancer, potentially leading to earlier detection and improved patient outcomes.

How similar studies have performed: Previous studies have shown promise in using breath tests for cancer detection, but this specific approach with the OWL-EVO1 probe is novel.

Eligibility criteria

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.

Where this trial is running

Prague, Prague and 8 other locations

• Thomayer Hospital — Prague, Prague, Czechia (Recruiting)
• National Koranyi Institute for Pulmonology — Budapest, Budapest, Hungary (Not_yet_recruiting)
• Department of Pulmonology, University of Debrecen — Debrecen, Debrecen, Hungary (Recruiting)
• Royal Papworth Hospital NHS Foundation Trust — Cambridge, Cambridgeshire, United Kingdom (Recruiting)
• Wythenshawe Hospital — Manchester, Greater Manchester, United Kingdom (Recruiting)
• Glenfield Hospital — Leicester, Leicestershire, United Kingdom (Recruiting)
• Barts Health NHS Trust — London, London, United Kingdom (Not_yet_recruiting)
• Imperial Centre for Translational and Experimental Medicine, Imperial College — London, London, United Kingdom (Recruiting)
• Quadram Institute — Norwich, Norfolk, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Robert Rintoul — Royal Papworth Hospital NHS Foundation Trust
• Study coordinator: Liz Thompson

Conditions Lung Cancer; Diagnostic Test; Diagnostic Breath test