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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mrs Katie Hamilton
+44 1312429180
k.hamilton@ed.ac.uk


Prof Kev Dhaliwal
+44 1312429180
kev.dhaliwal@ed.ac.uk


Mrs Joanne Mair
+44 1312429180
j.mair@ed.ac.uk


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Be Part of Research - Trial Details - LungSpy - Identifying lung disease by using novel imaging techniques
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LungSpy - Identifying lung disease by using novel imaging techniques

Not Recruiting

Open to: All Genders

Age: Adult

Edinburgh

Medical Conditions

Lung disease including infection inflammation and cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


When trying to identify lung diseases the current methods used only provide a snapshot of what is occurring in the lung. By using new technologies we hope to be able to characterise what is happening deep in the lung in order to provide new ways of diagnosing and treating lung disease. In the LungSpy study we hope to be able to develop and test novel technologies to be able to characterise disease deep in the lung. The technology includes tiny cameras that can reach far into the lung and can also deliver small volumes of fluid, called Smartprobes, which light up when they come into contact with cells that signify lung disease. Our imaging systems attach to the camera to allow these images to be viewed.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Apr 2022 21 Jul 2022

What does the study involve?
Eligibility screening involves a chest x-ray, a cardio respiratory examination and baseline clinical observations including, pulse, blood pressure, temperature and oxygen saturations.

The bronchoscope will be navigated into the lungs and a camera will be passed down the bronchoscope to the areas of interest. Small amounts of Smartprobes (less than a teaspoon of fluid) passed down a thin tube beside the camera into the lungs. Images of the lungs will be captured by the camera onto the video equipment (imaging system) The imaging and fluid delivery may be repeated in different areas of the lungs . As part of the bronchoscopy, the clinical team and the research team may need to collect some fluid samples from the lungs - this is called a bronchoalveolar lavage or BAL for short. It involves flushing some saline through the bronchoscope and collecting a fluid sample.

After the procedure, routine clinical observations will be recorded and participants may require a chest x-ray before being discharged home. 24 hours after the procedure, a member of the research team may contact the participant to check how they are.

What are the potential benefits and risks of participating?
We are testing these new imaging technologies to see if they can help clinicians distinguish between healthy and diseased lung tissue. The information we gain from this study will help us improve our understanding of lung disease and inform future development of the systems.

This is the first time that the imaging fibre (camera) has been used in humans. It has been tested extensively in the laboratory to image lung cancer, infection and inflammation. The imaging fibre comes into direct contact with the lung, therefore prior to being tested in humans, it has undergone rigorous safety testing to ensure that the materials used will not cause any harm. The imaging fibre will only be operated by a qualified member of the research team.

The imaging systems (video equipment) will not come into direct contact with the participant. There are two possible systems that can be utilised during the study. This is the first time one of the systems has been used in humans. The other system has been tested in two previous human research studies. Both systems have undergone all the required testing to ensure they are safe for use and will only be operated by qualified members of the research team.

We do not anticipate any adverse reactions to the Smartprobes that may be used in this study - only a very small amount of the Smartprobe will be used (also known as a microdose) and we have conducted extensive toxicology studies to demonstrate their safety for use in humans. Two out of the three Smartprobes have already been tested in humans and no side effects were experienced. If, however, an unexpected reaction was to occur, all of the necessary treatments are available in the hospital.

The risks of bronchoscopy are very low, with complications occurring in less than 1-2% of procedures. The main risk is air becoming trapped next to the lung which may require a chest drain. This is extremely rare. In addition, people can commonly experience cough, fever and sore throats within 24 hours following bronchoscopy.

Participants may have two chest x-rays (one before and one after the bronchoscopy). These procedures use ionising radiation to form images of your body and provide your doctor with clinical information. Ionising radiation can cause cell damage that may, after many years or decades, turn cancerous. We are all at risk of developing cancer during our lifetime. The normal risk is that this will happen to about 50% of people at some point in their life. Taking part in this study will add only a very small chance of this happening. The radiation exposure associated with these two additional x-rays is equivalent to approximately 7 days natural background radiation in the UK.

Where is the study run from?
The study is being run from the Royal Infirmary of Edinburgh (UK)

When is the study starting and how long is it expected to run for?
January 2021 to April 2027

Who is funding the study?
Wellcome Trust (UK)
UK Research and Innovation (UK)
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (UK)
Engineering and Physical Sciences Research Council (UK)

Who is the main contact?
Mrs Joanne Mair, j.mair@ed.ac.uk


We aim to recruit up to 80 participants with a variety of lung conditions. Participants must be aged over 16, have capacity to provide informed consent, deemed suitable for bronchoscopy and study procedures by attending consultant (including consideration of routine medical interventions) and they must be undergoing a clinically indicated bronchoscopy or agree to undergo a research only bronchoscopy for the purpose of the study.

You can take part if:



You may not be able to take part if:


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


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Infirmary of Edinburgh
    51 Little France Crescent Old Dalkeith Road
    Edinburgh
    EH16 4SA

We are testing these new imaging technologies to see if they can help clinicians distinguish between healthy and diseased lung tissue. The information we gain from this study will help us improve our understanding of lung disease and inform future development of the systems.
This is the first time that the imaging fibre (camera) has been used in humans. It has been tested extensively in the laboratory to image lung cancer, infection and inflammation. The imaging fibre comes into direct contact with the lung, therefore prior to being tested in humans, it has undergone rigorous safety testing to ensure that the materials used will not cause any harm. The imaging fibre will only be operated by a qualified member of the research team.
The imaging systems (video equipment) will not come into direct contact with the participant. There are two possible systems that can be utilised during the study. This is the first time one of the systems has been used in humans. The other system has been tested in two previous human research studies. Both systems have undergone all the required testing to ensure they are safe for use and will only be operated by qualified members of the research team.
We do not anticipate any adverse reactions to the Smartprobes that may be used in this study - only a very small amount of the Smartprobe will be used (also known as a microdose) and we have conducted extensive toxicology studies to demonstrate their safety for use in humans. Two out of the three Smartprobes have already been tested in humans and no side effects were experienced. If, however, an unexpected reaction was to occur, all of the necessary treatments are available in the hospital.
The risks of bronchoscopy are very low, with complications occurring in less than 1-2% of procedures. The main risk is air becoming trapped next to the lung which may require a chest drain. This is extremely rare. In addition, people can commonly experience cough, fever and sore throats within 24 hours following bronchoscopy.
Participants may have two chest x-rays (one before and one after the bronchoscopy). These procedures use ionising radiation to form images of your body and provide your doctor with clinical information. Ionising radiation can cause cell damage that may, after many years or decades, turn cancerous. We are all at risk of developing cancer during our lifetime. The normal risk is that this will happen to about 50% of people at some point in their life. Taking part in this study will add only a very small chance of this happening. The radiation exposure associated with these two additional x-rays is equivalent to approximately 7 days natural background radiation in the UK.

Mrs Joanne Mair
+44 1312429180
j.mair@ed.ac.uk


Mrs Katie Hamilton
+44 1312429180
k.hamilton@ed.ac.uk


Prof Kev Dhaliwal
+44 1312429180
kev.dhaliwal@ed.ac.uk



The study is sponsored by University of Edinburgh; NHS Lothian and funded by Wellcome Trust; UK Research and Innovation; Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator; Engineering and Physical Sciences Research Council.



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Read full details for Trial ID: ISRCTN10996089
Last updated 24 March 2025

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