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Development of New MRI Pulse Sequences for Probing Lung Function in Volunteers With Hyperpolarised 3He Gas

This study is currently recruiting participants.
Verified May 2017 by Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT01235494
First Posted: November 5, 2010
Last Update Posted: May 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Sheffield
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
  Purpose
To develop techniques with MRI of Helium-3 gas to give functional images of the lungs. The goal is to test a single breath-hold functional 3-He MRI pulse sequence with sensitivity to multiple functional aspects of the luncg physiology. A group of 20 healthy volunteers willbe recruited from the local research group and the results compared with existing methods that require seperate breath-holds of 3He gas

Condition Intervention Phase
Healthy Volunteers Other: polarised 3 helium Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Development of New MRI Pulse Sequences for Probing Lung Function in Volunteers With Hyperpolarised 3He Gas

Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Estimated Enrollment: 20
Actual Study Start Date: July 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: polarised 3 helium
inhaled gas
Other: polarised 3 helium
1 inhalation (= 1 litre)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18 -70

Exclusion Criteria:

  • contraindication to MRI
  • Resting oxygen saturation <95%
  • Volunteers requiring bronchodilators less than 4 hourly
  • additional respiratory diagnoses
  • pregnancy
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01235494


Locations
United Kingdom
Academic Unit of Radiology, Univeristy of Sheffield Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2SJ
Contact: Jim Wild, Professor    0114 2265393    l.armstrong@shef.ac.uk   
Principal Investigator: Paul Grififths, Professor         
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield
  More Information

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01235494     History of Changes
Other Study ID Numbers: STH15080
First Submitted: November 4, 2010
First Posted: November 5, 2010
Last Update Posted: May 5, 2017
Last Verified: May 2017