Healthy Lung Study- Development of 3T MRI Hardware and Software for 3He Gas Imaging of the Lung: Healthy Volunteer Development Study

NCT ID: NCT03169673

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-21
• Study Completion Date: 2025-01-31

Brief Summary

Healthy volunteers aged 18-75 will undergo hyperpolarized 3-Helium MRI and pulmonary function testing for the development of tools to assess image signal to noise and reproducibility of spin-density and diffusion-weighted imaging.

Detailed Description

During a two hour visit, subjects will provide written informed consent and then undergo: 1) brief medical history and vital signs, 2) full pulmonary function tests, 3) proton MRI, 4) spin-density and/or diffusion weighted 3He MRI.

Full pulmonary function tests including spirometry, plethysmography and diffusing capacity of carbon monoxide (DLCO), Lung Clearance Index (LCI) and Airwave Oscillometry (AO) will be performed according to ATS guidelines. MedGraphics Elite Series, MedGraphics Corporation. St. Paul, MN USA and/or nDD EasyOne Spirometer, nDD Medical Technologies Inc. Andover, MA USA will be used. All measurements will be performed in the Pulmonary Function Laboratory at Robarts Research Institute.

Subjects will be placed in the 3T MR scanner with the 3He chest coil fitted over their torso and chest. Hearing protection will be provided to each subject to muffle the noise produced by the gradient RF coils. A pulse oximeter lead will be attached to all of the subjects to monitor their heart rate and oxygen saturation. MRI will be performed for up to a period of 30 minutes. All subjects will have supplemental oxygen available via nasal cannula at a flow-rate of 2 liters per minute as a precaution in the event of oxygen desaturation.

Conditions

Healthy Volunteers

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Hyperpolarized Helium 3 Magnetic Resonance Imaging

Hyperpolarized noble gas imaging using Helium-3 has been used to explore structural and functional relationships in the lung in patients with lung disease and healthy controls. In contrast to proton-based MRI imaging, 3He gas is used as a contrast agent to directly visualize the airways, and thus ventilation. Whereas the normal density of gas is too low to produce an easily detectable signal, this is overcome by artificially increasing the amount of polarization per unit volume using optical pumping.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Able to perform a breath hold for up to 16 seconds.
• BMI between 18 and 40.
• Stable health on the basis of medical history.
• Smoking history < 1 pack/year.

Exclusion Criteria

• Patient is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material.
• Subject has a daytime room air oxygen saturation <90% while lying supine.
• Patient is unable to perform spirometry or plethysmography maneuvers
• Patient is pregnant
• In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia.
• Subject has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

London Health Sciences Centre

OTHER

Sponsor Role: collaborator

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Dr. Grace Parraga

PhD, Scientist. Robarts Research Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grace E Parraga, PhD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator Robarts Research Institute, The University of Western Ontario

Locations

Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

References

Capaldi DPI, Guo F, Xing L, Parraga G. Pulmonary Ventilation Maps Generated with Free-breathing Proton MRI and a Deep Convolutional Neural Network. Radiology. 2021 Feb;298(2):427-438. doi: 10.1148/radiol.2020202861. Epub 2020 Dec 8.

Reference Type: DERIVED

PMID: 33289613 (View on PubMed)

Other Identifiers

ROB0006

Identifier Type: -

Identifier Source: org_study_id