PAXT: Pulmonary Imaging of Mild Asthma Using 129Xe MRI and Tc-99-Labeled-Carbon-Imaging (Tc99CImaging)

ConditionMild Asthma

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age17-35

SponsorDr. Grace Parraga

About this trial

The goal of this observational study is to better understand how asthma affects the lungs in young adults (ages 17-35) with mild asthma. The main questions it aims to answer are:

* Can advanced imaging detect abnormal airway function in people with mild asthma? * Do changes in ventilation imaging correlate with asthma symptoms or quality of life? Researchers will compare hyperpolarized xenon-129 MRI and Technegas (Tc-99m) imaging to see if these techniques reveal more detailed lung abnormalities than standard lung function tests.

Participants will:

* Complete a single 2-hour visit * Undergo two types of lung imaging: Hyperpolarized xenon-129 MRI (to visualize how air moves in the lungs), Technegas (Tc-99m) imaging (to assess airflow using nuclear medicine) * Perform spirometry and other breathing tests * Answer questionnaires about asthma symptoms and quality of life This study is designed to improve our understanding of subtle changes in lung function that may not be detected by standard tests in people with mild asthma. The findings may lead to better diagnostic tools and more personalized treatment strategies in the future.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant diagnosed with mild (GINA1) asthma by physician

Participant understands study procedures and is willing to participate in the study as indicated by the participant's signature

Provision of written, informed consent prior to any study specific procedures

Males and females 17 to 35 years of age

Disqualifiers

Participant 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)

In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, CT, or Tc99CImaging, such as severe claustrophobia

Participants who are pregnant, breastfeeding or have a positive pregnancy test at initial screening visit

Participant is unable to perform spirometry or plethysmography maneuvers

Trial population

Participants will be young adults aged 17 to 35 years with physician-diagnosed mild asthma, consistent with Global Initiative for Asthma (GINA) Step 1 criteria. All participants will be prescribed short-acting bronchodilators for as-needed use only and will have no regular controller medication use. Eligible individuals must be otherwise healthy, non-smokers (or with ≤5 pack-year history and no smoking in the past year), and free from other chronic respiratory diseases. Participants will be recruited from the general population and will undergo a single, comprehensive imaging and lung function assessment visit.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Hyperpolarized 129Xe MRI
Other intervention
Inhalation of hyperpolarized 129Xe gas followed by breath-hold MRI for ventilation imaging.
Tc-99m Technegas Ventilation Imaging
Other intervention
Inhalation of Tc-99m-labeled carbon aerosol (Technegas) followed by SPECT imaging to assess lung ventilation.

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: Mild Asthma2 interventions

Trial outcomes

Primary outcomes

Measure 129Xe and Tc99C Imaging ventilation defects qualitatively and quantitatively in participants diagnosed and treated as "mild" asthma.

Ventilation defects will be assessed using 129Xe MRI and Tc-99m Technegas SPECT imaging. Measurements will include ventilation defect percentage (VDP) and visual scoring to evaluate ventilation abnormalities in participants with mild asthma.

Time frame

1 baseline visit for pre- and post-bronchodilator imaging assessments

Secondary outcomes

Evaluate the relationships of MRI and Tc99CImaging ventilation defects with ACQ, oscillometry (R5-19) and FEV1

In this exploratory study, we hypothesize that there will be significant relationships between ventilation abnormalities and oscillometry as well as FEV1 and asthma control questionnaire (ACQ) score.

Time frame

1 baseline visit

Sponsors and contacts

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

Dr. Grace Parraga

Lead sponsor

Western University, Canada

Sponsor institution

Cyclomedica Australia PTY Limited

Collaborator

Source ClinicalTrials.gov

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