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

NCT02736422 | Completed Phase 1 DMC

• 1 other identifier: STH15603
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Qualitative assessment of images 1

  signal to noise ratio,

  Baseline

• Qualitative assessment of images 2

  spatial resolution

  Baseline

• Qualitative assessment of images 3

  presence of artifacts

  Baseline

Study Arms (1)

hyperpolarised xenon

OTHER

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

Interventions

Hyperpolarised Xenon 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.

hyperpolarised xenon

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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').

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Academic Unit of Radiology, Univeristy of Sheffield

Sheffield, South Yorkshire, S10 2SJ, United Kingdom

Location

Study Officials

• Paul Griffiths

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: April 13, 2016
• Study Start: July 1, 2011
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 30, 2022

Record last verified: 2019-06

Locations

GB (1)