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

• ClinicalTrials.gov Identifier: NCT02736422
• Recruitment Status: Completed
• First Posted: April 13, 2016
• Last Update Posted: September 30, 2022
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Information provided by (Responsible Party): Sheffield Teaching Hospitals NHS Foundation Trust

Tracking Information

• First Submitted Date: March 18, 2016
• First Posted Date: April 13, 2016
• Last Update Posted Date: September 30, 2022
• Actual Study Start Date: July 2011
• Actual Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 21, 2016)

• 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

Original Primary Outcome Measures (submitted: April 7, 2016)

• Qualitative assessment of images [ Time Frame: Baseline ]
  signal to noise ratio,
• Qualitative assessment of images [ Time Frame: Baseline ]
  spatial resolution
• Qualitative assessment of images [ Time Frame: Baseline ]
  presence of artifacts

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of New Magnetic Resonance Imaging (MRI) Pulse Sequences for Imaging Hyperpolarised Xenon in Lung, Heart and Brain in Volunteers
• Official Title: Assessment of New Magnetic Resonance Imaging (MRI) Pulse Sequences for Imaging Hyperpolarised Xenon in Lung, Heart and Brain in Volunteers
• 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.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: 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.

Study Arms

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

Intervention: Other: Hyperpolarised Xenon

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 7, 2016): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 31, 2020
• Actual Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02736422
• Other Study ID Numbers: STH15603
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
• Original Responsible Party: Same as current
• Current Study Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Paul Griffiths; Sheffield Teaching Hospitals NHS Foundation Trust

• PRS Account: Sheffield Teaching Hospitals NHS Foundation Trust
• Verification Date: June 2019