Evaluation of Ventilation Defects Downstream of Mucus Plugs in Patients With Muco-Obstructive Lung Disease

ConditionsSevere Asthma COPD Non-CF Bronchiectasis Cystic Fibrosis (CF)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-65

SponsorUniversity of Kansas Medical Center

About this trial

In this study, xenon MRI will be used to evaluate regional functional consequences of mucus plugs in the lungs of patients with muco-obstructive pulmonary disease. Mucus plugs will be identified using CT imaging, and xenon MRI will be used to evaluate ventilation and gas exchange impairments in regions of the lungs corresponding to the airways downstream of mucus plugs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adequate completion of informed consent process with written documentation

Patients 18 - 65 years old

• Physician diagnosis of muco-obstructive pulmonary disease, including cystic fibrosis, severe asthma, chronic obstructive pulmonary disease, or non-cystic fibrosis bronchiectasis for > 1 year

Able to perform reproducible spirometry according to ATS criteria based on clinical PFTs.

Disqualifiers

Respiratory tract infection within the 4 weeks prior to Visit 1

Body mass index (BMI) > 30 at Visit 1

One-time doses such as intra-articular injections require a 4-week washout prior to Visit 1

ER visit related to pulmonary condition within the previous 4 weeks of Visit 1

Trial population

Patients with muco-obstructive pulmonary disease, including COPD, non-CF bronchiectasis, Severe Asthma, or cystic fibrosis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Hyperpolarized 129 Xenon
Combination product
Xenon gas contrast agent for MRI

Treatment groups

8 Participants

are divided into 1 treatment group

Group A: Main Group1 intervention

Trial outcomes

Primary outcomes

Ventilation Defect in Mucus blocked Regions

The primary endpoint of this study is the ventilation defect percent (VDP; measured by Xe-MRI) in regions of the lungs that are downstream of mucus plugs (identified on CT imaging).

Time frame

Baseline

Secondary outcomes

Changes to Gas Exchange with Bronchodilator

1\) The change in regional gas exchange markers following administration of a bronchodilator.

Time frame

Baseline

Sponsors and contacts

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

University of Kansas Medical Center

Lead sponsor

Polarean Imaging, Plc

Collaborator

Source ClinicalTrials.gov

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