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

NCT01235494 | Completed Phase 1

• 1 other identifier: STH15080
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Study Arms (1)

polarised 3 helium

EXPERIMENTAL

inhaled gas

Other: polarised 3 helium

Interventions

polarised 3 helium OTHER

1 inhalation (= 1 litre)

polarised 3 helium

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 -70

You may not qualify if:

• contraindication to MRI
• Resting oxygen saturation \<95%
• Volunteers requiring bronchodilators less than 4 hourly
• additional respiratory diagnoses
• pregnancy

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Academic Unit of Radiology, Univeristy of Sheffield

Sheffield, South Yorkshire, S10 2SJ, United Kingdom

Location

Study Design

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

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 5, 2010
• Study Start: July 1, 2010
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 29, 2021

Record last verified: 2021-12

Locations

GB (1)