LungSpy
Research type
Research Study
Full title
Probing molecular signatures in human lung disease using novel optical technologies; LungSpy
IRAS ID
249631
Contact name
Kevin Dhaliwal
Contact email
Sponsor organisation
University of Edinburgh
Clinicaltrials.gov Identifier
To be completed, To be completed
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Research Summary
Clinical Medicine is hampered by a lack of incisive clinical tools to inform on key events and processes in tissues. An exemplar of this, is lung disease. In suspected or confirmed lung diseases, invasive lung biopsies and pathological assessment of tissue provides only a snapshot of the disease processes that are occurring in the distal lung. The introduction of methodologies that would be able to visualise key processes deep in the gas exchanging regions of the human lung could provide a paradigm changing approach to assessing disease and trialling new therapies. This is the key driver for this clinical programme, which aims to develop a suite of technology to visualise structures in the human lung and also image pathological processes that have been highlighted by the use of imaging systems and/or the delivery of small amounts of chemical Smart Probes.
Tiny amounts of chemical Smartprobes may be sprayed into the deepest parts of the human lung, emitting light or fluorescence when they attach to specific targets that provide information about disease pathology at the microscopic level. This light is then detected using an imaging system connected to fibre-optic tubes that are small enough to be threaded deep inside patients’ lungs, thereby revolutionising how suspected lung diseases are assessed and will guide subsequent treatment.
This clinical protocol is designed to allow new technologies (including Smartprobes) to be brought in at a later date to effectively evaluate novel methods for diagnosing lung disease. In this current version a novel imaging fibre, two imaging systems and three Smartprobes are being evaluated for feasibility and safety.
Up to 80 participants with a variety of suspected lung conditions will be recruited from within the Royal Infirmary of Edinburgh. Patients will undergo a bronchoscopy and be followed up for up to 4 hours after the procedure.
Summary of Results
The LungSpy study was designed to evaluate safety and feasibility of molecular imaging techniques to visualise key processes of disease in the distal lung that are not currently captured using routine clinical technologies.
The focus was in patients with suspected or confirmed lung disease to image the suspected affected area of the lung during a bronchoscopy procedure and gain further information using imaging agents or ‘SmartProbes’. One SmartProbe, called NAP, was used in this study. NAP is designed to detect inflammation and is a fluorescent which means that it lights up areas of the lung where cells and proteins associated with inflammation are present. It is this light that the study was aiming to detect using a small fibre-based microscope (Panoptes) along with an imaging device with a screen (KronoScan and Versicolour).
12 participants were consented to the trial between 06th June and 21st July 2022. 2 participants were withdrawn, one due to a co-enrolment issue and the other failed screening post-consent. We successfully performed the research procedure in 10 participants as part of their clinically indicated bronchoscopy. The indications for the clinical bronchoscopies were cancer (4 participants), inflammation (3 participants), and infection (3 participants).
The primary objective of the trial was to demonstrate safety and feasibility of optical technologies in patients undergoing a clinically indicted bronchoscopy. The endpoints for the primary objective were split into safety and feasibility, and all participants were assessed on both to determine if the primary objective of the study was achieved. The primary endpoint of safety was met in all 10 participants and the primary endpoint of feasibility was met in 9 out of 10 of the participants.
There was no formal analysis involved in this study. We have undertaken a descriptive analysis of the participant data summarising the feasibility and safety objectives which was provided to the Data Monitoring and Safety Committee but there is an insufficient number of participants for a more robust assessment.
The study was terminated early due to an ongoing device deficiency associated with the manufacture of the Panoptes imaging fibre (related to performance, not safety). We hoped to introduce a new, improved imaging device iteration to the LungSpy clinical investigation. However, we were formally advised by the MHRA that this will not be possible and a new iteration of the imaging fibre will necessitate a new application. Continuation of LungSpy using the currently approved iteration is untenable. As such, the LungSpy clinical investigation was terminated with immediate effect.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
21/WM/0199
Date of REC Opinion
7 Oct 2021
REC opinion
Further Information Favourable Opinion