Health TrialsbyHealthPanel

Structure and Function MRI of Asthma

ConditionAsthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorDr. Grace Parraga

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Hyperpolarized Noble Gas MRI

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Asthma PatientsOther 1 intervention

Trial outcomes

Primary outcomes

1

Ventilation Defect Percent as measured by Xenon-129 and/or Helium-3 MRI

VDP is a widely used noble gas MRI biomarkers that is calculated by normalizing ventilation defect volume to the thoracic cavity

Time frame
3 years

Secondary outcomes

1

Forced Expiratory Volume (FEV1) measured by spirometry

The volume of air that is exhaled in the first second is referred to as FEV1

Time frame
3 years
2

Additional Pulmonary Function measurements

Measurements include Functional Residual Capacity (FRC); Total Lung Capacity (TLC); Inspiratory Capacity (IC); Airway Resistance (Raw); Forced Vital Capacity (FVC); FEV1/FVC Ratio

Time frame
3 years
3

Quality of Life questionnaires

questionnaires

Time frame
3 years
4

Dyspnea Scale

Scale

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Grace Parraga

Lead sponsor

Western University, Canada

Sponsor institution

Source ClinicalTrials.gov
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