Recruiting

Observational Study

Sponsor:

University of Kansas Medical Center

Code:

NCT06985225

Conditions

Severe Asthma

COPD

Non-CF Bronchiectasis

Cystic Fibrosis (CF)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized 129 Xenon

Study Details

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.

Conditions

Severe Asthma

COPD

Non-CF Bronchiectasis

Cystic Fibrosis (CF)

Study ID

NCT06985225

Start date

Jun 1, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

8 participants

Anticipated

Interventions and Outcome Measures

Arms

Main Group

Patients with Severe Asthma with a high T2 phenotype

Interventions

Hyperpolarized 129 Xenon

Xenon gas contrast agent for MRI

Primary outcome measure

  • Ventilation Defect in Mucus blocked Regions [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Cristal Monge

(913) 945-9399chernandez@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Cristal Monge

(913) 945-9399chernandez@kumc.edu

Principal Investigator:

Peter Niedbalski, PhD

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Xenon MRI
  • Mucus Plug
  • Severe Asthma
  • COPD
  • Non-CF Bronchiectasis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-07-01.