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Novel evaluations of patients with Primary Pneumothorax using xenon enhanced MRI scan and advanced lung function tests.

Oxford Sub-study of Randomised Ambulatory Management of Primary Pneumothorax

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN56742377
Enrollment
20
Registered
2018-08-15
Start date
2017-02-08
Completion date
Unknown
Last updated
2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders

Interventions

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 r

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
There are no secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026