Recruiting

Observational Study

Sponsor:

Dr. Grace Parraga

Code:

NCT02351141

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized Noble Gas MRI

Study Details

Brief summary:

The investigators will apply 129Xenon and/or 3He image acquisition and analysis methods in 200 asthma patient volunteers in order to characterize and probe the relationship between lung structure and function using imaging.

Conditions

Asthma

Study ID

NCT02351141

Start date

Jan, 2015

Status verified date

Jul, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects male and female aged 18-60 with a clinical diagnosis of asthma
  • Smoking history ≤ 1 pack/year
  • Subject understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent
  • Subject is judged to be in otherwise stable health on the basis of medical history
  • Subject able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater.)
  • FEV1 >60% predicted

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
  • Patient is unable to perform spirometry or plethysmography maneuvers
  • 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.) (At the discretion of the MRI Technologist/3T Manager)
  • 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.
  • Patient is pregnant

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Asthma Patients

All enrolled asthma patients will undergo hyperpolarized noble gas MRI with Helium-3 and/or Xenon-129, Pulmonary Function Tests, Quality of Life Questionnaires, dyspnea scales in two visits over three years.

Interventions

Hyperpolarized Noble Gas MRI

Hyperpolarized Helium-3 and/or Xenon-129. Noble gas magnetic resonance imaging (MRI) has recently emerged as another research approach for the non-invasive measurement of lung structure and function, including conduction of gas through airways and into airspaces.

Noble gas MRI provides a complimentary and alternative method for evaluating lung disease and may be superior to CT because it allows simultaneous visualization of both airway and airspace structure and function.

Primary outcome measure

  • Ventilation Defect Percent as measured by Xenon-129 and/or Helium-3 MRI [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Grace E Parraga, PhD

519-931-5265gparraga@robarts.ca

Angela P Wilson, RRT

519-931-5777awilson@robarts.ca

Locations

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

Recruiting

London, Ontario, Canada, N6A 5B7

Contacts

Grace E Parraga, PhD

519-931-5265gparraga@robarts.ca

Angela P Wilson, RRT

519-931-5777awilson@robarts.ca

More Information

Sponsor

Dr. Grace Parraga

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • Noble Gas MRI
  • Pulmonary Function
  • Quality of Life Questionnaires

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Grace Parraga on 2026-07-31.