Diagnostic Accuracy Study for OWL-EVO1 As a Lung Cancer EVOC® Probe (Evolution Phase 2)
Trial Parameters
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Brief 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.
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 treatm