NCT06193239

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Owlstone Ltd · Industry
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	OWL-EVO1	EVOC probe

Timeline

• Start date: 2023-10-05
• Primary completion: 2025-04-25
• Completion: 2025-04-30
• First posted: 2024-01-05
• Last updated: 2024-10-15

Locations

9 sites across 3 countries: Czechia, Hungary, United Kingdom