Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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Xenon MRI to Evaluate Changes to Lung Function Following Bronchoscopic Treatment of Air Trapping in Emphysema

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

The objective of this study is to provide a regional, mechanistic characterization of pulmonary ventilation changes following treatment with the Apreo BREATHE System, using hyperpolarized ¹²⁹Xe MRI, in BREATHE-3 participants. BREATHE-Xe is designed to generate mechanistic signals regarding whether airway scaffolds reduce ventilation defects, improve gas exchange, and correlate with CT and spirometric/plethysmographic changes observed in BREATHE-3. Findings support mechanistic interpretation and future hypothesis generation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 84
Healthy Volunteers: f
View:

• Enrolled and randomized in BREATHE-3 to the Treatment arm or enrolled as a Control arm participant who has elected crossover treatment following BREATHE-3 Month 12.

• Separate written BREATHE-Xe informed consent obtained prior to any sub-study procedures.

• Able to perform coached breath-hold maneuvers of ≥10 seconds, as assessed by the site investigator.

• Willing and able to travel to KUMC or UAB for all scheduled Xe-MRI sessions.

• Eligible for MRI per local MRI safety screening, with no contraindications to MRI.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Kansas
University of Kansas Medical Center (KUMC)
NOT_YET_RECRUITING
Kansas City
Contact Information
Primary
Nina Mohmood
Nina.Mohmood@ApreoHealth.com
650-326-2656
Backup
Cindy Holtz
CindyHoltz@ApreoHealth.com
Time Frame
Start Date: 2026-10
Estimated Completion Date: 2028-11
Participants
Target number of participants: 15
Treatments
Other: XENOVIEW
Hyperpolarized ¹²⁹Xe (HP ¹²⁹Xe) gas (XENOVIEW, Polarean; NDA 214375), administered by inhalation as an MRI signal agent. Produced on-site immediately prior to use under site-held INDs: IND 151978 (KUMC); IND 178832 (UAB).
Sponsors
Leads: Apreo Health, Inc.
Collaborators: University of Kansas Medical Center, University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov

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