Lung cancer Cancer
Conditions
Interventions
As this is a non-randomised, early-stage medical device investigation, a control/placebo group has not been included.
Non-clinical interventions:
1. Informed consent: taken once per participant by an
Sponsors
University of Edinburgh & Lothian Health Board ACCORD
Eligibility
Sex/Gender
All
Age
16 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. =16 years old 2. Suspected or confirmed lung malignancy 3. Undergoing a clinically indicated bronchoscopy and deemed suitable for study procedures by the attending consultant (including consideration of routine medical interventions) 4. Capacity to provide informed consent 5. Complies with co-enrolment criteria as outlined in Clinical Protocol (section 6.4.9)
Exclusion criteria
Exclusion criteria: 1. Currently pregnant 2. Unlikely to tolerate the bronchoscopy study procedure in the opinion of the attending clinician or operator 3. Currently receiving long-term oxygen therapy or ambulatory therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of devices (KronoScan and EoT) will be assessed by: 1. The acquisition of cancer and non-cancer imaging data (with a minimum of 30 frames, at a rate of at least 2.8 frames per second) per area imaged during a clinically indicated bronchoscopy procedure at the time of image analysis (after the bronchoscopy procedure). Safety of the devices will be assessed by: 1. The number of adverse events that occur, assessed at the following timepoints: enrolment (post-consent), pre-bronchoscopy, during bronchoscopy, 1 hour post-bronchoscopy, 4 hours post-bronchoscopy, 24 hours and 7 days post-bronchoscopy 2. The number of device deficiencies that occur, assessed during the bronchoscopy 3. Routine clinical monitoring methods including: 3.1. Cardiorespiratory examinations assessed pre-bronchoscopy and 4 hours post-bronchoscopy 3.2. Chest X-ray or computed tomography (CT) scan assessed at screening and enrolment (based on any results done previously as part of clinical care that are within 3 months of the date of bronchoscopy) and again at 4 hours post-bronchoscopy as part of clinical care. (However, it will not be considered a deviation if done >8 hours post-bronchoscopy). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The ability to obtain in vivo fluorescence lifetime metabolic signatures in cancerous and non-cancerous lesions will be measured using imaging data of suspected cancerous vs control areas taken during the bronchoscopy. The imaging data will then be correlated with the signatures reported with the pathology results from samples taken during the bronchoscopy. 2. The capability of EoT to sample or facilitate sampling of tissue for the assessment of lung pathologies will be measured using samples obtained during the bronchoscopy and the pathologist's report on the quality and volume of these samples for making a pathological assessment. | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactJean Antonelli
Outcome results
None listed