Recruiting

Xenon MRI

Sponsor:

Bastiaan Driehuys

Code:

NCT07139899

Conditions

Severe Asthma

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized Xenon 129

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 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 ID

NCT07139899

Start date

Nov 17, 2025

Status verified date

Nov, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Nov, 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 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.

Study Design

Enrollment

5 participants

Anticipated

Interventions and Outcome Measures

Interventions

Hyperpolarized Xenon 129

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

Primary outcome measure

  • Ventilation Defect in Mucus-blocked regions [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

David Mummy, PhD

9846847783david.mummy@duke.edu

Bastiaan Driehuys, PhD

919-684-7786bastiaan.driehuys@duke.edu

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27713

More Information

Sponsor

Bastiaan Driehuys

Last update posted

Nov 20, 2025

Last verified

Nov, 2025

Keywords

  • xenon
  • asthma
  • mucus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bastiaan Driehuys on 2025-11-20.