Technical Development of Xe MRI

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT07823010
Phase
PHASE1/PHASE2
Status
Enrolling By Invitation

Conditions

  • HSCT
  • Lung Transplant Recipient

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Hyperpolarized 129 Xenon — DRUG
    The total dosing volume will be consistent with CCHMC Department of Radiology clinical standards or up to 1/6th of a participant's total lung capacity (calculated or predicted from ATS guidelines or from participant's plethysmography data if available within 6 months of MRI scan) for participants under 18 years old and 1000 milliliters for adults. No more than a total of five Xe gas doses, combined clinical and research doses, will be administered during the scanning session.

Study Details

The goal of this study is to develop and optimize new proton (1H; conventional MRI) and Xe gas MRI techniques to assess regional cardiopulmonary structure and function in the clinical setting. Specifically, three forms of Xe MRI techniques will be our focus: (1) imaging of the Xe ventilation distribution (which is the current FDA-approved indication for Xe MRI); (2) imaging the alveolar microstructure via the Xe apparent diffusion coefficient (ADC); and (3) detecting via spectroscopy and imaging Xe gas dissolved in the pulmonary blood and tissues upon inhalation.

Key Dates

First listed
Sep 16, 2026
Start date
Jan 1, 2024
Status verified
Jan 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
550 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Hyperpolarized 129 Xenon
    This research study will happen immediately following the clinical MRI exam with additional research Xe doses administered after the clinical Xe MRI procedure. Xe gas will be administered to the participant in the same manner as the clinical Xe MRI scan. Research scans without Xe gas may be acquired as well.

Primary Outcome Measure

Xenon gas Defect Distribution Index (DDI) [ Time Frame: Through study completion, an average of 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-

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