Identifying and investigating abnormal areas on the lung using UV light
| ISRCTN | ISRCTN14196090 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14196090 |
| IRAS number | 263552 |
| Secondary identifying numbers | IRAS 263552 |
- Submission date
- 28/01/2020
- Registration date
- 12/03/2020
- Last edited
- 08/08/2022
- Recruitment status
- Suspended
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Pneumothorax is air in the chest which causes the lung to collapse. This can occur spontaneously without any other injury to the chest. Primary spontaneous pneumothorax (PSP) usually refers to young patients without known lung disease, who were traditionally thought to have normal lungs. This view is now being challenged, but the true reason for their lung to leak air (and hence collapse) is not known.
This study will use a new technique to show up abnormal areas in the lung by asking patients to inhale a drug called fluorescein. Fluorescein glows bright green under ultraviolet (UV) light. Therefore, when a patient has surgery to prevent another collapsed lung, we can use UV light to show where the fluorescein is coming abnormally close to the lung surface.
We think these areas are the source of the air leak and will therefore have a different structure with some chemicals being over- (or under-) produced. The lung structure (histology) will be looked at under the microscope and the chemicals being produced (mRNA) will be analysed. Importantly, we will be comparing areas that look normal and abnormal in the same patient and also with other patients who have not had a pneumothorax (the control group).
Who can participate?
Patients aged 16 – 55 years, either undergoing Video-assisted Thoracoscopic Surgery (VATS) or thoracic surgery.
What does the study involve?
During surgery patients will be asked to breathe in Fluorescein to show up any abnormal areas on the lung surface.
The surgery will not be any difference to usual, but within the part of the lung removed, 2 or 3 areas will be used for analysis. Patients will also be asked to perform some extra breathing tests (lung function), if time allows, before your surgery, and to provide a blood sample (5ml).
What are the possible benefits and risks of participating?
The study is not designed to change this participants treatment, but an increased understanding of the causes of pneumothorax may benefit patients in the future.
The procedure is very safe and the surgery will not take longer than usual. The lung tissue that used for analysis is tissue that would have been removed anyway. Fluorescein has been used in this way before with no reported side effects, except for a slight yellow discolouration of the mouth, which goes away after 1-2 days. The laser system used for measuring the levels of oxygen and carbon dioxide uses a low power system and the light is entirely enclosed within the device and is therefore harmless.
Where is the study run from?
Oxford Centre for Respiratory Medicine (UK)
When is the study starting and how long is it expected to run for?
March 2020 to March 2026
Who is funding the study?
1. Oxfordshire Health Services Research Committee (UK)
2. Medical Sciences Division Research Fund (University of Oxford) (UK)
Who is the main contact?
Dr Rob Hallifax
Robert.Hallifax@ndm.ox.ac.uk
Contact information
Scientific
Oxford Centre for Respiratory Medicine
Churchill Hospital
Old Road
Oxford
OX3 7LE
United Kingdom
 ORCID ID |
0000-0002-9467-668X |
|---|---|
| Phone | +44 (0)7989966210 |
| Robert.Hallifax@ndm.ox.ac.uk |
Study information
| Study design | Exploratory study |
|---|---|
| Primary study design | Other |
| Secondary study design | |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Primary pneumothorax fluorescein-enhanced thoracoscopy |
| Study acronym | PREFECT |
| Study hypothesis | The underlying cause of primary spontaneous pneumothorax is not known. We hypothesize that abnormal areas can be highlighted by use of inhaled fluorescein at thoracic surgery, and the abnormalities can be quantified by a combination of histological analysis of subpleural architecture and mRNA expression. |
| Ethics approval(s) | Approved 17/09/2019, East of England - Cambridgeshire and Hertfordshire Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +44 (0)207 104 8106; nrescommittee.eastofengland-cambsandherts@nhs.net), ref: 19/EE/0235 |
| Condition | Primary spontaneous pneumothorax |
| Intervention | Administration of inhaled fluorescein at Thoracic Surgery to highlight areas of lung abnormalities. During surgery patients will be asked to breathe in Fluorescein to show up any abnormal areas on the lung surface. The surgery will not be any different to usual, but within the part of the lung removed, 2 or 3 areas will be used for analysis. Patients will also be asked to perform some extra breathing tests (lung function), if time allows, before your surgery, and to provide a blood sample (5ml). The samples will be looked at under the microscopy (histology) and by mRNA analysis. No additional patient follow-up is required. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Descriptive histological findings in lung areas under investigation, measured by the researchers |
| Secondary outcome measures | 1. Lung genomic analysis measured using mRNA sequencing 2. Autofluorescence measured using digital image analysis software 3. Degree of lung inhomogeneity measured using laser gas analyser (bespoke project with University of Oxford Department of Physiology) 4. Peripheral blood genomic analysis measured using mRNA sequencing |
| Overall study start date | 01/06/2019 |
| Overall study end date | 01/03/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 28 |
| Participant inclusion criteria | 1. Patient undergoing Video-assisted Thoracoscopic Surgery (VATS) for pneumothorax recurrence prevention, or ongoing air leak (pneumothorax group) OR Thoracic surgery for another indication, for example, early-stage lung cancer or metastasis resection (control group). 2. Male or female aged between 16 and 55 years (inclusive) |
| Participant exclusion criteria | 1. Inability to consent or comply with the trial requirements 2. Patients in the control group should not have demonstrable emphysema (on CT scanning) and should not have experienced a spontaneous pneumothorax in the past 3. Allergy to fluorescein 4. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the trial, or the participant’s ability to participate in the study |
| Recruitment start date | 01/03/2020 |
| Recruitment end date | 01/09/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Old Road
Oxford
OX3 7LE
United Kingdom
Sponsor information
University/education
Clinical Trials and Research Governance
Joint Research Office, Block 60
Churchill Hospital
Old Road
Oxford
OX3 7LE
England
United Kingdom
| Phone | +44 (0)1865 572228 |
|---|---|
| ctrg@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | 01/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The preparation of a manuscript for rapid publication in a peer reviewed journal will be a priority for and responsibility of the Chief Investigator. The Study Management Group will also take responsibility for reviewing drafts of any manuscripts, abstracts, press releases and other publications arising from this study. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V1.0 | 18/06/2019 | 12/03/2020 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN14196090_PROTOCOL_V1.0_18Jun2019.pdf
- Uploaded 12/03/2020
Editorial Notes
08/08/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/09/2021 to 01/09/2025.
2. The intention to publish date has been changed from 01/09/2022 to 01/09/2026.
11/07/2022: The overall trial end date has been changed from 01/03/2022 to 01/03/2026 and the plain English summary updated accordingly.
09/04/2020: Due to current public health guidance, recruitment for this study has been paused.
12/03/2020: Uploaded protocol Version 1.0, 18 June 2019 (not peer reviewed).
11/02/2020: Trial’s existence confirmed by East of England - Cambridgeshire and Hertfordshire Research Ethics Committee.
