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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.
See Contacts and Locations
Verified May 2017 by Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor:
Collaborator:
University of Sheffield
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01235494
First received: November 4, 2010
Last updated: May 4, 2017
Last verified: May 2017
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 4, 2010
Last Updated: May 4, 2017

ClinicalTrials.gov processed this record on September 21, 2017