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Enrolling by invitation

NCT Number: NCT07823010

Technical Development of Xe MRI

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.

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Key information

Conditions

HSCT Lung Transplant Recipient

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant is having a clinically-ordered hyperpolarized Xe gas MRI scan

Exclusion criteria

  • Pregnancy or positive pregnancy test
  • Standard MRI exclusions

Treatment and study plan

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.

Primary outcomes

  1. Xenon gas Defect Distribution Index (DDI)

    Time frame: Through study completion, an average of 5 years

    The signal intensity of Xe gas in a voxel (in arbitrary units) as compared to neighboring voxels, with a higher DDI indicating more clustered and focal Xe defects.

Secondary outcomes

  1. Apparent-Diffusion Coefficient (ADC) of Xe gas within the alveolar airspace.

    Time frame: Through study completion, an average of 5 years

    Measurement of the Xe apparent-diffusion coefficient (ADC), in units of cm^2/s, with a larger value indicating more airspace dilation.

  2. Xenon RBC:Membrane ratio

    Time frame: Through study completion, an average of 5 years

    The ratio of Xe signal intensity (in arbitrary units) within the red-blood cell (RBC) compartment and membrane (interstitial tissue) compartments of pulmonary diffusion measured during dissolved-phase Xe MRI.

  3. Xe gas time constant

    Time frame: Through study completion, an average of 5 years

    The rate at which Xe gas signal intensity changes during dynamic images, in arbitrary units/second.

  4. Length in time of Xe MRI acquisition

    Time frame: Through study completion, an average of 5 years

    Measurement of time in seconds for the duration of the Xe MRI acquisition.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Technical Development of Xe MRI in Children and Adults

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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