Assessment of New Magnetic Resonance Imaging (MRI) Pulse Sequences for Imaging Hyperpolarised Xenon in Lung, Heart and Brain in Volunteers

Healthy Volunteers Clinical Trial

Official title:

Assessment of New Magnetic Resonance Imaging (MRI) Pulse Sequences for Imaging Hyperpolarised Xenon in Lung, Heart and Brain in Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736422
• Other study ID #: STH15603
• Status: Completed
• Phase: Phase 1
• Start date: July 2011
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2019
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Any sex.

• Age greater than 18, less than 80.

NB: Participants will also be permitted to take part in study STH15080 (Eudract number 2009-010815-34, 'Development of new Magnetic resonance imaging (MRI) pulse sequences for probing lung function in volunteers with hyperpolarised 3He gas').

Exclusion Criteria:

• Contraindication to MRI.

• Resting oxygen saturation less than 90%.

• Known disease of the lungs, heart or brain.

• Pregnant.

Volunteer eligibility will be determined by completion of the study screening form not by physical examination or testing. Eligibility will be confirmed by a clinician upon review of the study screening form, prior to completing the study prescription for xenon dosing.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Academic Unit of Radiology, Univeristy of Sheffield	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative assessment of images 1	signal to noise ratio,	Baseline
Primary	Qualitative assessment of images 2	spatial resolution	Baseline
Primary	Qualitative assessment of images 3	presence of artifacts	Baseline