Regional Phenotyping of CF and Non-CF Bronchiectasis

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT04793867
Status
Recruiting
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Conditions

  • Cystic Fibrosis
  • Non-CF Bronchiectasis

Eligibility Criteria

Sex
ALL
Age
5 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Xenon — DRUG
    Subjects will be scanned on a commercial 3T whole-body MRI scanner equipped with high-performance gradient systems. Natural isotopic abundance or isotopically-enriched xenon gas (\~86% 129Xe, Linde Inc.) will be used for all studies. Subjects will be positioned supine in the scanner with a 129Xe RF coil around their chests. Using conventional proton MRI and a breath-hold acquisition, "scout" images will be obtained to localize the subject for subsequent 129Xe acquisitions. 129Xe images will be acquired using the same breath-hold maneuver and a pulse sequence, covering the entire lung (acquisition time \<10 s, approximately 3-mm in-plane resolution, 15-mm slice thickness or less). Additional scans (sequences) may be performed. A maximum of 4 doses of 129Xe will be given throughout the study following the calibration dose.

Study Details

The Investigators propose to study pediatric subjects who are diagnosed with cystic fibrosis (CF) and patients with non-CF bronchiectasis, with the goal of developing markers of CF lung disease severity, progression, and therapy response. The Investigator's central hypothesis is that image-based markers can forecast pathophysiology prior to spirometric changes.

Key Dates

Start date
Feb 8, 2021
Status verified
Feb 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: CF and Non-CF Bronchiectasis
    In the first arm (Aims 1 \& 2) Up to 50 subjects will be recruited-approximately 25 with normal FEV1 (\>85% predicted) and 25 with mild to moderate disease. All subjects will be asked to undergo longitudinal (i.e., approximately annually) 129Xe and UTE MRI, spirometry, and lung clearance index (LCI) measurement.
  • Arm: Healthy Subjects
    Up to 50 age and sex matched control subjects (i.e., subjects with no known cardiopulmonary disorders) may also be recruited to provide a reference data set from healthy subjects for comparison.

Primary Outcome Measure

Correlation of ventilated volume predictions obtained with 129Xe MRI vs 1H MRI [ Time Frame: Annually for 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penny NewCincinnatiOhio45229
Penny A New, BBA
[email protected]
513-332-7931
Zackary Cleveland, PhD (PRINCIPAL_INVESTIGATOR)

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