Assessment of New Magnetic Resonance Imaging (MRI) Pulse Sequences for Imaging Hyperpolarised Xenon in Lung, Heart and Brain in Volunteers
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|ClinicalTrials.gov Identifier: NCT02736422|
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : June 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Other: Hyperpolarised Xenon||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of New Magnetic Resonance Imaging (MRI) Pulse Sequences for Imaging Hyperpolarised Xenon in Lung, Heart and Brain in Volunteers|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
evaluating the sensitivity of pulse sequences for 129Xe magnetic resonance imaging in the lungs, heart and brain and monitoring the transient changes in vital signs during and following the gas inhalation
Other: Hyperpolarised Xenon
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.
- Qualitative assessment of images 1 [ Time Frame: Baseline ]signal to noise ratio,
- Qualitative assessment of images 2 [ Time Frame: Baseline ]spatial resolution
- Qualitative assessment of images 3 [ Time Frame: Baseline ]presence of artifacts
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736422
|Contact: Paul Griffithsfirstname.lastname@example.org|
|Academic Unit of Radiology, Univeristy of Sheffield||Recruiting|
|Sheffield, South Yorkshire, United Kingdom, S10 2SJ|
|Contact: Jim Wild, Professor 0114 2265393 email@example.com|
|Principal Investigator: Paul Grififths, Professor|
|Principal Investigator:||Paul Griffiths||Sheffield Teaching Hospitals NHS Foundation Trust|