Recruiting
Phase 1
Phase 2

Xe MRI

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT07823036

Conditions

HSCT

Respiratory

Gas Exchange Impairment

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Accepted

Interventions

Hyperpolarized 129 Xenon

Study Details

Brief summary:

This will be an un-blinded, open-label study of children and adults, including those who are being evaluated for or who have undergone HSCT, those with existing respiratory conditions and/or diagnosed gas-exchange impairment, and healthy control volunteers. The participants will be male or female between 3-17 years old (children) and adults age 18 and older.

The study objective is to:

  • To optimize the acquisition of images reflecting the "dissolved-phase" Xe distribution in the pulmonary tissues and blood (Xe gas-exchange MRI).
  • To develop and test Xe MRI acquisition strategies that separately image alveolar airspace distribution (ventilation), as well as Xe dissolved in pulmonary tissues versus red blood cells (RBCs).
  • To acquire images of Xe ventilation and dissolved-phase Xe regional distribution in the enrolled participants.
  • To understand the same-day variability of Xe MRI techniques.
  • To determine the relationship between Xe MRI and clinical measures such as pulmonary-function-test (PFT) parameters or other biological biomarkers.
  • To develop and optimize strategies for Xe MRI in young children including those who are unable to follow the inhalation and breath-hold instructions typical of the Xe MRI procedure.

Conditions

HSCT

Respiratory

Gas Exchange Impairment

Study ID

NCT07823036

Start date

Jul 24, 2024

Status verified date

Sep, 2025

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Ages 3 years and older

Exclusion Criteria:

  • Pregnancy or positive pregnancy test
  • Baseline oximetry at MRI visit of less than 90% on room air or less than 90% on a previously prescribed dosage of oxygen delivered by nasal cannula. In some cases of cardiorespiratory disease, if the participant is referred to this research study by their treating physician and considered stable for imaging, the cardiorespiratory criteria will be 5% of their clinical baseline. This should be documented in the research record upon referral of a participant that meets this scenario.
  • Any condition in the opinion of the investigator that would make the participant unable to tolerate the MRI procedure (e.g., neurocognitive delay, behavioral issues).
  • Standard MRI exclusions (e.g., metal, incompatible implants).

Study Design

Enrollment

550 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Hyperpolarized 129 Xenon

Hyperpolarized xenon gas will be administered in doses of up to 1/6TLC (based on either ATS calculations that utilize gender and height to determine the dose or plethysmography data) for participants under 18 years old and 1000 milliliters for adults per our previous research experience followed by a breath hold of up to 16 seconds

Interventions

Hyperpolarized 129 Xenon

Hyperpolarized xenon gas will be administered in doses of up to 1/6TLC (based on either ATS calculations that utilize gender and height to determine the dose or plethysmography data) for participants under 18 years old and 1000 milliliters for adults per our previous research experience followed by a breath hold of up to 16 seconds

Primary outcome measure

  • Xe Gas-Exchange MRI [ Time Frame: Through study completion, an average of 5 years ]

Central Contacts and Locations

Central contacts

Ashley Borden, MPH

5136360143ashley.borden@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Ashley Borden, MPH

5136360143ashley.borden@cchmc.org

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Sep 16, 2026

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-09-16.