Lung disease including infection inflammation and cancer Respiratory
Conditions
Interventions
Participants will undergo a bronchoscopy. A camera will be passed down the bronchoscope to the areas of interest. Small amounts of Smartprobes may be passed down the bronchoscope into the lungs. Image
Sponsors
University of Edinburgh
NHS Lothian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged = 16 years 2. Deemed suitable for bronchoscopy and study procedures by attending consultant (including consideration of routine medical interventions) 3. Capacity to provide informed consent 4. Readily accessible target areas with bronchoscopy (or navigational bronchoscopy where clinically indicated) and fibre based endoscopy 5. Complies with sponsor co-enrolment criteria 6. Undergoing a clinically indicated bronchoscopy or agrees to undergo a research only bronchoscopy for the purpose of the study
Exclusion criteria
Exclusion criteria: 1. History of anaphylaxis 2. Documented history of allergy to fluorescein 3. Women (of childbearing potential) who are pregnant or are breastfeeding 4. Currently prescribed drugs that cause increased autofluorescence in the lung, specifically amiodarone and methotrexate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: 1. Completion of the research element of the bronchoscopy procedure utilising the technology (yes/no) 2. The imaging fibre reaches and is navigated to areas of interest in the lung (yes/no) 3. Imaging fibre delivers small volumes of liquids to areas of interest in the lung (Smartprobes and/or saline) (yes/no) Safety assessed using routine clinical observations: 4. Pre-and post-procedure pulse, temperature, BP and cardiorespiratory exam. 5. O2 saturation during bronchoscopy procedure 6. Pre discharge (from bronchoscopy) BP, temp and pulse 7. Recording adverse events that occur up to 4 hours post procedure (pre discharge) and 24 hours post procedure. 8. Safety reporting for the medical devices | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at the time of procedure unless otherwise noted: 1. Delivery of SmartProbes will be assessed by the fluid leaving the syringe attached to the imaging fibre. 2. FLIM signatures obtained during visualisation of suspected cancerous tissue will be compared with clinical pathology results from the patient’s resected tissue and ex vivo imaging of the resected lung tissue. Images obtained demonstrating bacterial presence and inflammatory signatures will be compared with the participants suspected pathology. 3. Safety of the procedure will be assessed by routine clinical monitoring – and recording any adverse events that occur during and/or post-procedure (up to 1 hour post procedure) and pre discharge (up to 4 hours post procedure). 4. The ability to perform a distal microlavage will be measured by the retrieval of a sufficient volume of Alveolar lavage to perform PCR. The lavage sample results will be compared to the appropriate SmartProbe signature. | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactJoanne;Katie Mair;Hamilton
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Outcome results
None listed