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NCT Number: NCT06985225

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

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyperpolarized 129 Xenon

Combination Product

Xenon gas contrast agent for MRI

Primary outcomes

  1. 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

  1. Changes to Gas Exchange with Bronchodilator

    Time frame: Baseline

    • The change in regional gas exchange markers following administration of a bronchodilator.

Study contacts

Contact information is provided by the study sponsor or research team.

Cristal Monge

CONTACT

[email protected]

(913) 945-9399

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Polarean Imaging, Plc

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 22, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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