Lung cancer Cancer
Conditions
Interventions
Group 1: Lung cancer patient – administered the OWL-EVO1 probe at a maximum dose of 2mg/kg intravenously. The patients will be administered one dose of the probe on the first study day and may be call
Sponsors
Owlstone Medical Limited
Eligibility
Sex/Gender
All
Age
45 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 45-85 years 2. Ability to provide informed consent 3. Receiving a thoracic CT
Exclusion criteria
Exclusion criteria: 1. Anticipated inability to complete the breath sampling procedure (e.g., inability to maintain adequate ventilation unaided or claustrophobia). 2. Received an investigational medical product in the context of a Clinical Trial (CTIMP) during the 28 days prior to administration of the (first) probe. 3. Individuals under diagnostic investigation for a potential malignancy other than lung cancer that has not yet reached a conclusive diagnosis*. 4. Individuals with an inconclusive lung abnormality (indeterminate pulmonary nodule) on CT-scan requiring CT-based monitoring rather than biopsy and/or treatment. 5. 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. 6. Pregnant or breastfeeding women and women of child-bearing potential not using adequate contraceptive methods. 7. 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; Individuals with a confirmed cancer diagnosis ARE eligible (such as a diagnosis of prostate cancer now undergoing hormone therapy). Individuals scheduled to attend a cancer screening program; prostate, breast, lung, colon, ARE eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnostic accuracy of OWL-EVO1 to distinguish between those with lung and without lung cancer on breath measured using breath samples taken on Day 1 pre- and post-infusion, reported using a Receiver Operator Characteristic Curve, NPV, PPV, Sensitivity, Specificity & Likelihood Ratios. Metrics will be reported for overall test performance as well as pre-defined subgroup analyses. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Optimised test: Locked down protocol for breath sampling (method, timing, posture and duration) and OWL-EVO1 dose at Day 1 pre and post infusion breath samples 2. Safety and tolerability: Refined understanding of safety and tolerability of OWL-EVO1 based on reported Adverse Events associated with probe administration. AEs assessed on Day 1 and phone call between day 3 and 5 post infusion | — |
Countries
Czech Republic, England, Hungary, United Kingdom
Outcome results
None listed