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Assessing Pulmonary Changes in HSCT

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07823036
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Conditions HSCT, Respiratory, Gas Exchange Impairment
Enrollment 550 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov