About this trial
Patients with signs of radiation induced lung inflammation, who are referred for a clinical bronchoscopy for investigation, will have a sample sent for single cell sequencing. This is a novel technique which allows for identification of which cells are present and what they are doing. This hopes to better understand radiation pneumonitis, a dose-limiting toxicity in cancer treatment which can be highly morbid and even fatal.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years
Patient has received thoracic radiotherapy and has clinical or radiological features in fitting with a diagnosis of Radiation Pneumonitis (onset one to four months post-RT with breathlessness, especially exertional, cough, chest discomfort, which is persistent over weeks, a chest x-ray [CXR] may demonstrate patchy or widespread opacification although can be normal.)
Must be ambulant, oxygen independent with SpO2 >92% on air and haemodynamically stable to be considered safe for a bronchoscopy.
Willing to undergo and likely able to tolerate bronchoscopy, ie. Can lie flat without compromising ventilation, and able to consent to the ELFMAN Protocol and SPITFIRE trial.
Disqualifiers
Contraindication to bronchoscopy, ie. Previously not tolerated, unable to lie flat, Sp02 <92% on air
Patient requires admission or oxygen dependant
Test positive for Covid-19 within the preceding six weeks to enrolment
Trial population
Patients meeting the above eligibility criteria who demonstrate clinical/radiological diagnosis of radiation pneumonitis
Trial design
Case-only
Prospective
Treatments tested in this trial
Single Cell Sequencing
Diagnostic testSequencing of all viable single cells present in deep bronchial brushings using transcriptomics to identify what cells are present and what they are doing.
Treatment groups
Trial outcomes
Primary outcomes
Successful creation of dataset
If deep bronchial brushings generates sufficient viable cells for processing via single-cell sequencing this will generate a dataset of cellular activity for each of these five patients. The only way to know if this technique - ie. the use of deep bronchial brushings combined with single-cell sequencing, is to run the test on the samples and therefore successful generation of the dataset is proof of feasibility of the method. There may be further use for this dataset (ie. secondary outcome below) but primarily this process will prove feasibility simply by generating data. This is not a health outcome, simply demonstration of a viable sample using a novel combination of sampling and laboratory test.
Secondary outcomes
Signals in pneumonitis
Comparison with normal lung dataset (publicly available) to potentially identify radiation pneumonitis signals that may be targetable via drug therapy or worth expanding to a larger trial to explore.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.