Condition category
Respiratory
Date applied
22/01/2018
Date assigned
15/08/2018
Last edited
16/08/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study looks into why some people have a pneumothorax (collapsed lung). The study will comprise of two parts. The study includes Magnetic Resonance Imaging (MRI) scanning with Xenon enhancement to determine the initial association between Xe-129 lung MRI findings and recurrence rates for primary spontaneous pneumothorax. It also includes breathing tests to determine whether lung function testing and a novel laser gas analyser can identify abnormalities in patients with PSP. This study will recruit people already enrolled into the RAMPP (Randomised Ambulatory Management of Primary Pneumothorax) study in Oxford. We will ask around 20 patients enrolled in Oxford with spontaneous pneumothorax to participate after completion of their treatment for pneumothorax

Who can participate?
Adults aged 18 and older who are enrolled in the RAMPP study.

What does the study involve?
On completion of treatment for their pneumothorax, eligible participants are approached about the study and consented. Ideally within the first 3 months post removal of chest drain, participants are asked to attend for Xenon-129 MRI scan (an MRI scan during which patients will be breathing in Xenon gas) and Lung Function Test: standard and using the Laser Gas Analyser. The Laser Gas Analyser study consists of a 30 min period when the patient breathes either through a facemask or through a mouthpiece while wearing a noseclip. The mouthpiece is connected to the gas analyser. The patient initially breathes air (baseline) and then for the middle ten minutes breathes 100% oxygen (N2 washout period) and back to air again. Following the MRI scanning participants will receive a telephone consultation to check if they have experienced any adverse reactions 24 hours after the scan. If they have, participants will be contacted at a further 24 hours, and then weekly to ensure resolution. The patients will be followed up for 12 months as standard (as part of RAMPP study) and for an additional 12 months as part of OX-RAMPP only (24 months in total). At 24 months, patients will be assessed again to assess evolution of abnormalities over time and long-term recurrence rates.

What are the possible benefits and risks of participating?
This study may lead to better diagnosis and treatments for patients with pneumothorax. As the study is not designed to change current patients’ treatment, it is unlikely that they will benefit directly from taking part. Xenon and MRI imaging have been used separately in medicine for many years and we do not expect this procedure to be risky. Patients will be carefully monitored throughout the procedure under the supervision of a doctor. Breathing xenon during magnetic resonance imaging is a relatively new test, though both xenon and magnetic resonance imaging have been used separately for other purposes for many years. Sometimes scans of the lungs can show up a shadow or ‘nodule’ that was not known about before. If this happened, we would discuss the finding with patients, and would ensure that they had the best medical care to look into and treat this.There will be no radiation risk from the tests. 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. Patients will be expected to wear the activity monitor for ~23hrs per day for three weeks which may be inconvenient. However, the monitor is the size of a watch and should not be too bothersome.


Where is the study run from?
1. Churchill Hospital (UK)
2. Royal Berkshire Hospital (Patient Identification Centre only) (UK)

When is the study starting and how long is it expected to run for?
January 2017 to February 2019

Who is funding the study?
Medical Research Council (UK)

Who is the main contact?
Miss Magda Laskawiec-Szkonter (Scientific)
magda.laskawiec@ouh.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Magda Laskawiec-Szkonter

ORCID ID

Contact details

Clinical Trials Manager
Oxford Respiratory Trials Unit
University of Oxford
Churchill Hospital
Old Road
Oxford
OX3 7LE
United Kingdom
+44 (0)1865 225205
magda.laskawiec@ouh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33404

Study information

Scientific title

Oxford Sub-study of Randomised Ambulatory Management of Primary Pneumothorax

Acronym

OX-RAMPP

Study hypothesis

This study aims to look at differences in lungs of patients with primary spontaneous pneumothorax (PSP) using hyperpolarised xenon gas MRI and advanced lung function testing. The Xenon MRI provides more detailed images of the lungs and how they function (ventilation within the lungs). This will be performed for the first time in the context of PSP and correlated with clinical outcomes and recurrence rates. An in-development laser gas analyser will be used to determine lung ventilation to volume ratio in patients with primary spontaneous pneumothorax.

Ethics approval

South Central - Oxford A Research Ethics Committee, 19/09/2016, ref: 16/SC/0412

Study design

Observational; Design type: Validation of outcome measures

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Respiratory/ Other diseases of pleura

Intervention

Ideally within the first 3 months post removal of chest drain, patients will be asked to attend for Xe-129 MRI scan and Lung Function Test: standard and using the Laser Gas Analyser. Xe-129 lung MRI requires breathing in hyperpolarized xenon, Xe-129.

The Standard Lung Function and Laser Gas Analyser testing will take place 1-3 months post-completion of treatment (dependent upon the availability of the gas analyser). Standard Lung Function and Laser Gas Analyser testing will occur in the Lung Function Laboratory at the Churchill Hospital, Oxford. They can be performed before or after the Hyperpolarized Xe-129 MR imaging, ideally on the same day.

Standard lung function testing will performed on all patients, as per NHS Trust and national guidelines ideally prior to the Laser Gas Analyser testing. This will include:
1. Spirometry: FEV1 (Forced Expiratory Volume in 1 second), FVC (Forced Vital Capacity), FEV1/FVC ratio, and PEFR (Peak Expiratory Flow Rate).
2. Body plethysmography: TLC (Total Lung Capacity), Vital capacity (VC), Functional residual capacity (FRC) and RV (Residual Volume)
3. Diffusion capacity : DLCO (Diffusing Capacity for carbon monoxide), VA (Alveolar Volume), kCO (DLCO/VA diffusing capacity corrected for alveolar volume)

These parameters will allow assessment of any previously undiagnosed obstructive or restrictive defect, and any abnormality of oxygen transfer.

The Laser Gas Analyser study will consist of a 30 min period when the patient breathes either through a facemask or through a mouthpiece while wearing a noseclip. The mouthpiece will be connected to the gas analyser. The patient initially breathes air (baseline) and then for the middle ten minutes breathes 100% oxygen (N2 washout period) and back to air again.

Post-Xe-MRI scan - Safety observation and Follow-up
The participant will receive a telephone consultation to review AE/SAE 24 hours after the scan. If there are any outstanding/non-resolved AE/SAE, the participant will be contacted at a further 24 hours, and then weekly to ensure resolution. The patients will be followed up for 12 months as standard (as part of RAMPP study) and for an additional 12 months as part of OX-RAMPP only (24 months in total). At 24 months, patients will be assessed again to assess evolution of abnormalities over time and long-term recurrence rates.
There is no need for any special safety observation period following the Lung Function and Laser Gas Analyser assessment.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Co-primary outcome measures:
1. Comparison of hyperpolarized Xe-129 MRI ventilation and diffusion-weighted maps i.e. percentage ventilation volumes (%VV) and ADC values (cm2/s) with findings from normal control patients (data collected from previous Xe MRI study) and correlation with recurrence rates at 12 months follow-up (in RAMPP study)
2. Ventilation/Volume abnormalities in PSP in comparison with standard lung function and with normal controls (from previous laser gas analyser study)

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/01/2017

Overall trial end date

28/02/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Recruited into RAMPP study through the Oxford or Reading centre (both interventional and observational cohort patients)
2. Participant is willing and able to give informed consent for participation in the study
3. Female participants of child bearing potential must agree to take appropriate steps to avoid pregnancy in the three months following the hyperpolarized xenon lung MRI scan
4. Male or female, aged 16-55

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 20; UK Sample Size: 20

Participant exclusion criteria

1. Inability to consent or comply with the trial requirements.
2. Inability to lie flat for procedures.
3. Contraindication to MRI examination (e.g. indwelling pacemaker, non-MRI compatible metallic implant, severe claustrophobia, intra-ocular foreign body).
4. Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
5. 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.
6. Epilepsy requiring on-going medical treatment, or a seizure within the past year.

Recruitment start date

08/02/2017

Recruitment end date

28/02/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Churchill Hospital
Old Road Headington
Oxford
OX3 7LE
United Kingdom

Trial participating centre

Royal Berkshire Hospital (Patient Identification Centre only)
Craven Road
Reading
RG1 5AN
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

-
Oxford
OX3 7GB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

28/02/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

16/08/2018: Internal review.