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NCT Number: NCT07823036

Assessing Pulmonary Changes in HSCT

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.

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Key information

Conditions

HSCT Gas Exchange Impairment Respiratory

Age range

3 year and older

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

Location status: Recruiting

Location contact

Ashley Borden, MPH

CONTACT

[email protected]

5136360143

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

Hyperpolarized 129 Xenon

Drug

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 outcomes

  1. Xe Gas-Exchange MRI

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

    Images reflecting dissolved-phase xenon distribution in pulmonary tissues and blood obtained by xenon MRI

Secondary outcomes

  1. Establish Aquisition Strategies for Xenon Ventilation Imaging

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

    Ventilation defect percentage (i.e., hypoventilated lung volume) will be analyzed following the xenon MRI

  2. Percentage difference between Xe MRIs repeated within the same-day

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

    Quantitative outcomes from Xe MRI scans, like the ventilation defect percentage (i.e., hypoventilated lung volume), from within the same participant will be compared using paired statistical tests to assess the same-day repeatability.

  3. Correlation between FEV1 and FEV1/FVC from spirometry with ventilation-defect percentage from Xe MRI.

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

    The correlation between FEV1 and FEV1/FVC measured in liters and/or percent predicted from reference equations and the VDP (ventilation defect percentage) from Xe MRI will be determined.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Borden, MPH

CONTACT

[email protected]

5136360143

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Assessing Pulmonary Changes in Hematopoietic Stem-Cell Transplantation Patients and Patients With Rare-Lung Diseases Using Hyperpolarized Xe MR Lung Imaging

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
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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