Assessing Pulmonary Changes in HSCT

NCT07823036 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 2023-0678
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Xe Gas-Exchange MRI

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

  Through study completion, an average of 5 years

Secondary Outcomes (3)

• Establish Aquisition Strategies for Xenon Ventilation Imaging

  Through study completion, an average of 5 years

• Percentage difference between Xe MRIs repeated within the same-day

  Through study completion, an average of 5 years

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

  Through study completion, an average of 5 years

Study Arms (1)

Hyperpolarized 129 Xenon

EXPERIMENTAL

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

Drug: Hyperpolarized 129 Xenon

Interventions

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

Hyperpolarized 129 Xenon

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 3 years and older

You may not qualify if:

• 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).

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Study Officials

• Laura Walkup, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Borden, MPH

CONTACT

5136360143; ashley.borden@cchmc.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: September 16, 2026
• Study Start: July 24, 2024
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: September 16, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)