Assessing Pulmonary Changes in HSCT

Conditions

• Gas Exchange Impairment
• HSCT
• Respiratory

Eligibility Criteria

Sex

ALL

Age

3 Years - N/A

Healthy Volunteers

Accepted

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

Study Details

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.

Key Dates

First listed

Sep 16, 2026

Start date

Jul 24, 2024

Status verified

Sep 2025

Primary completion

Jul 31, 2029

Completion

Jul 31, 2029

Study Design

Enrollment

550 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

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

Primary Outcome Measure

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

Central Contacts

• Ashley Borden, MPH
  5136360143
  [email protected]

Locations (1)

Find similar trials in Cincinnati, OH

Related Studies

• Technical Development of Xe MRI
  PHASE1/PHASE2 · Enrolling By Invitation · Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio
• MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing
  EARLY_PHASE1 · Recruiting · Vanderbilt University Medical Center · Nashville, Tennessee