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RECRUITING
NCT07823036
PHASE1/PHASE2

Assessing Pulmonary Changes in HSCT

Sponsor: Children's Hospital Medical Center, Cincinnati

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

3 Years - Any

Study Type

INTERVENTIONAL

Enrollment

550

Start Date

2024-07-24

Completion Date

2029-07

Last Updated

2026-09-16

Healthy Volunteers

Yes

Interventions

DRUG

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

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States