Downstream Effects of Airway Mucus Plugs on 129Xenon MRI in Severe Asthma

NCT ID: NCT07139899

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-17
• Study Completion Date: 2027-09-30

Brief Summary

In this study, xenon MRI will be used to evaluate regional functional consequences of mucus plugs in the lungs of patients with severe asthma. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Hyperpolarized Xenon 129

Pulmonary magnetic resonance imaging using hyperpolarized xenon-129 gas as an inhaled contrast agent

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Adequate completion of informed consent process with written documentation
• Patients 18 - 65 years old
• Physician diagnosis of asthma for > 1 year
• Able to perform reproducible spirometry according to ATS criteria based on clinical PFTs within previous 30 days of enrollment
• All racial/ethnic backgrounds may participate
• Blood eosinophil count > 300 cells/μL
• Smoking history <10 pack years
• No smoking history (including vapes, cigar, or marijuana use) in the last 3 months
• About to initiate asthma therapy with either dupilumab, tezepelumab, or benralizumab as part of their standard of care

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
• Asthma-related ER visit within the previous 4 weeks of Visit 1 or at any time while on the study
• 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 cannula
• Positive urine pregnancy test at Visit 1 or at any time while on the study
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: collaborator

Polarean, Inc.

INDUSTRY

Sponsor Role: collaborator

Bastiaan Driehuys

OTHER

Sponsor Role: lead

Responsible Party

Bastiaan Driehuys

Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David Mummy, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Mummy, PhD

Role: CONTACT

david.mummy@duke.edu

9846847783

Bastiaan Driehuys, PhD

Role: CONTACT

bastiaan.driehuys@duke.edu

919-684-7786

Other Identifiers

Pro00117680

Identifier Type: -

Identifier Source: org_study_id