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Study finishedPhase2

Diagnostic Accuracy Study for OWL-EVO1 as a Lung Cancer EVOC® Probe (Evolution Phase 2)

Sponsor: Owlstone Ltd

NCT ID: NCT06193239

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
OWL-EVO1 (diagnostic test)
How long the study runs
Study runs about 19 months (dates as stated)
About the drug or intervention
OWL-EVO1 — diagnostic test: EVOC probe
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
45 Years to 85 Years
Who
All
Number of participants
187
Started
2023-10-05
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for lung cancer
  • • Phase2 - 187 participants
  • • The Phase 2a Evolution study aims to assess the diagnostic accuracy of the OWL-EV1 Probe Breath Biopsy Test to differentiate between individuals with lung cancer and relevant contrast groups

Who can take part?

  • • Ages 45 Years to 85 Years
  • • Diagnosed with lung cancer

Where?

  • • Cambridge - Royal Papworth Hospital NHS Foundation Trust
  • • Manchester - Wythenshawe Hospital
  • • Leicester - Glenfield Hospital
  • • London - Barts Health NHS Trust
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The Phase 2a Evolution study aims to assess the diagnostic accuracy of the OWL-EV1 Probe Breath Biopsy Test to differentiate between individuals with lung cancer and relevant contrast groups. The contrast groups will be representative of the clinical populations in which the test is intended to be used. Thus, Evolution Phase 2a will be designed as a cross-sectional, case-control trial that will be conducted at various sites, both in the UK and EU.

More detail

In Evolution Phase 1, Owlstone Medical demonstrated the safety and tolerability of their Exogenous Volatile Organic Compound (EVOC) Probe. This phase also demonstrated proof of mechanism for the cleavage of the EVOC Probe, D5-ethyl-βD-glucuronide (OWL-EVO1), into D5-ethanol which can be detected on breath. This makes OWL-EVO-1 a promising EVOC Probe for the detection of lung cancer. The Evolution Phase 2a study will evaluate the diagnostic accuracy of an OWL-EVO1 based breath test for the differentiation of those with histopathologically confirmed lung cancer and relevant contrast groups with a CT-proven absence of lung cancer. These contrast groups will include those with relevant comorbidities, to truly evaluate accuracy and the robustness of test performance. As a secondary objective, the study aims to define a test protocol that minimises healthcare worker effort, whilst maximising tolerability and diagnosed accuracy for the intended use setting. This phase intends to recruit up to 150 cases and 200 controls. Both cohorts will be administered the probe intravenously. Multiple breath samples will be collected for up to 180 minutes post-probe infusion, with the cumulative sampling time not exceeding 60 minutes. The study results will provide valuable insights into the expected test performance as well as optimisation of the test in a clinical pathway.

Lung Cancer

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 45 Years - 85 Years
  • Who can join: All genders

What the study is looking for

  • ✓Aged 45-85 years.
  • ✓Ability to provide agreement to take part.
  • ✓BMI 16 - \<40.
  • ✓Receiving a CT including the thoracic region, within the last 6 months.

Who cannot take part

  • ✗(Anticipated) inability to complete the breath sampling procedure (e.g., inability to maintain adequate ventilation...
  • ✗Potential subjects who in the opinion of the investigator lack mental capacity.
  • ✗Individuals under diagnostic investigation for a potential cancer other than lung cancer that has not yet...
  • ✗Individuals with an inconclusive lung abnormality (indeterminate lung nodule) on CT-scan requiring CT-based...
  • ✗Pregnant or breastfeeding women and women of child-bearing potential not using adequate contraceptive methods...
See the full 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 Is This Study? (6 UK sites)

Royal Papworth Hospital NHS Foundation Trust

Cambridge CB2 0AY, United Kingdom

Hospital R&D contact (matched)

Vikki Hughes

papworth.randdenquiries@nhs.net01223 638000

Wythenshawe Hospital

Manchester M23 9LT, United Kingdom

Glenfield Hospital

Leicester LE3 9QP, United Kingdom

Barts Health NHS Trust

London E1 1FR, United Kingdom

Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

Imperial Centre for Translational and Experimental Medicine, Imperial College

London W12 0HS, United Kingdom

Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

Quadram Institute

Norwich NR4 7UQ, United Kingdom

Hospital R&D contact (matched)

Julie Dawson

rdsubmissions@nnuh.nhs.uk01603 286611
Data sourced from ClinicalTrials.gov · Last verified: 2026-07