Diagnostic Accuracy Study for OWL-EVO1 as a Lung Cancer EVOC® Probe
Key facts
- Where
- Budapest XII és Debrecen, MagyarországSee the 2 sites
- Phase
- 2. fázis
Where in Magyarország
- Koranyi National Institute For PulmonologyBudapest XII, MagyarországNo longer taking part
- University of DebrecenDebrecen, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Owlstone Medical Limited
- Trial code
- EU 2023-503574-20-00
- Record updated
- 2025. március 10.
- Original description
Diagnostic accuracy: To assess diagnostic accuracy of the OWL-EVO1 Breath Biopsy test (OBBT) to differentiate between individuals with relevant clinical presentations in which the test is intended to be used (lung cancer and contrast groups representing clinical presentation that include lung cancer as part of its differential diagnosis).Read full original descriptionShow less
Diagnostic accuracy: To assess diagnostic accuracy of the OWL-EVO1 Breath Biopsy test (OBBT) to differentiate between individuals with relevant clinical presentations in which the test is intended to be used (lung cancer and contrast groups representing clinical presentation that include lung cancer as part of its differential diagnosis).
In this context relevant clinical presentations means:
Individuals eligible for lung cancer screening based on low dose CT with or without lung cancer.
Incidental findings on CT-scan suspicious of lung cancer
Clinical presentations which include lung cancer as part of their differential diagnosis
Inclusion: 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: 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; 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); Individuals under diagnostic investigation for a potential malignancy other than lung cancer that has not yet reached a conclusive diagnosis; 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; (Anticipated) inability to complete the breath sampling procedure (e.g., inability to maintain adequate ventilation unaided or claustrophobia); Potential subjects if in the opinion of the investigator lack mental capacity; Individuals with an inconclusive lung abnormality (indeterminate pulmonary nodule) on CT-scan requiring CT-based monitoring rather than biopsy and/or treatment; 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); Further to the above stated exclusion criteria, in the interest of subject safety, exclusion of any subject is at the ultimate discretion of the investigator. This includes (but is not limited to) subjects who are acutely unwell according to investigator assessment.