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

NCT ID: NCT02736422

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2020-12-31

Brief 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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

hyperpolarised xenon

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

Group Type: OTHER

Hyperpolarised Xenon

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Griffiths

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

Academic Unit of Radiology, Univeristy of Sheffield

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

STH15603

Identifier Type: -

Identifier Source: org_study_id