Assessment of New Magnetic Resonance Imaging (MRI) Pulse Sequences for Imaging Hyperpolarised Xenon in Lung, Heart and Brain in Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Hyperpolarised gas Magnetic resonance imaging (MRI) (Hyperpolorised 3He and 129Xe MRI)
      provides novel regional functional images of the lungs. Over the past 14 years researchers at
      Sheffield Teaching Hospitals NHS Foundation Trust and University of Sheffield have been
      developing and evaluating different MRI techniques to investigate different aspects of the
      lung function with both Hyperpolorised 3He and more recently 129Xe gas and have tested these
      new methods in volunteers with healthy and diseased lungs. This proposed study is to further
      test the sensitivity of MRI pulse sequences with inhaled 129Xe gas in volunteers. This
      protocol serves to evaluate the sensitivity of pulse sequences for 129Xe magnetic resonance
      imaging in the lungs and monitoring the transient changes in vital signs during and following
      the gas inhalation. This includes evaluation of pulse sequences to image xenon in the heart
      and brain as well as in the lungs of volunteers.
    

Detailed description: 
      The primary endpoints are to test the pulse sequences under development to image lung
      ventilation and perfusion, cardiac perfusion and brain uptake of xenon

      The study will seek to test the given pulse sequence under investigation in a group of up to
      40 volunteers.

      To be eligible, each subject will have no contraindications to MRI scanning and will have
      signed the necessary volunteer consent forms.

      The target recruitment number should provide sufficient data to determine the efficacy of the
      techniques under development.

      Methods HP 129Xe MRI scans will be performed. MRI images will be acquired with the patients
      supine inside a 129Xe-capable MRI system, (1.5 Tesla GE, USA or 3.0 Tesla Philips,
      Netherlands), using dedicated transmit-receive radio-frequency coils.

      129Xe is hyperpolarised on site to >50% polarisation using a Rubidium spin exchange
      polariser, and administered through a Tedlar bag. The 129Xe polarisation process has
      regulatory approval as an IMP for lung imaging from the MHRA (UK-MAIMP-29724). 129Xe will be
      manufactured as required for study volunteers. Manufactured 129Xe is held in a bag prior to
      administration to the study participant. Bags of manufactured gas will be labelled using
      labels approved by the MHRA. Drug accountability records will be held in the site file to
      document the administration of 129Xe to study participants. Hyperpolarised 129Xe will be
      prescribed to the participants prior to administration by a medically qualified study
      investigator using the study-specific prescription.

      Subjects will be asked to go through several test runs of the inhalation procedure prior to
      imaging without actually starting to inhale the contents of the administration bag. The
      subject's heart rate and oxygen saturation will be monitored continuously during the studies
      using magnetic resonance compatible monitoring equipment.
    

Intervention name(s): Hyperpolarised Xenon
Intervention type(s): Other
Intervention description(s): Hyperpolarised gas Magnetic resonance imaging (MRI) (3He and 129Xe) has enabled novel methods of in-vivo functional lung imaging that do not rely on the use of ionising radiation.
Intervention MeSH terms: Xenon
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic