NCT06985225RecruitingNot Applicable
Evaluation of Ventilation Defects Downstream of Mucus Plugs in Patients With Muco-Obstructive Lung Disease
University of Kansas Medical Center1 site in 1 country8 target enrollmentStarted: June 1, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Ventilation Defect in Mucus blocked Regions
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
- •Significant concomitant medical illness, including (but not limited to) heart disease, cancer, uncontrolled diabetes, other chronic lung diseases (determined by the Investigator.)
- •Resting O2 saturation <90% with maximum supplemental O2 delivered by nasal canula
- •Positive urine pregnancy test
- •Participation in an intervention study (including bronchoscopy) or use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study
- •Unable or unlikely to complete study assessments in the opinion of the Investigator
- •Study intervention poses undue risk to patient in the opinion of the Investigator
- •Conditions that will prohibit MRI scanning determined by the MRI safety screening.
Arms & Interventions
Main Group
Patients with Severe Asthma with a high T2 phenotype
Intervention: Hyperpolarized 129 Xenon (Combination Product)
Outcomes
Primary Outcomes
Ventilation Defect in Mucus blocked Regions
Time Frame: Baseline
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).
Secondary Outcomes
- Changes to Gas Exchange with Bronchodilator(Baseline)
Investigators
Study Sites (1)
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