Technical Development of Xe MRI

NCT07823010 | Enrolling By Invitation Phase 1 FDA Drug

• 1 other identifier: 2023-0524
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to develop and optimize new proton (1H; conventional MRI) and Xe gas MRI techniques to assess regional cardiopulmonary structure and function in the clinical setting. Specifically, three forms of Xe MRI techniques will be our focus: (1) imaging of the Xe ventilation distribution (which is the current FDA-approved indication for Xe MRI); (2) imaging the alveolar microstructure via the Xe apparent diffusion coefficient (ADC); and (3) detecting via spectroscopy and imaging Xe gas dissolved in the pulmonary blood and tissues upon inhalation.

Conditions

HSCT; Lung Transplant Recipient

Outcome Measures

Primary Outcomes (1)

• Xenon gas Defect Distribution Index (DDI)

  The signal intensity of Xe gas in a voxel (in arbitrary units) as compared to neighboring voxels, with a higher DDI indicating more clustered and focal Xe defects.

  Through study completion, an average of 5 years

Secondary Outcomes (4)

• Apparent-Diffusion Coefficient (ADC) of Xe gas within the alveolar airspace.

  Through study completion, an average of 5 years

• Xenon RBC:Membrane ratio

  Through study completion, an average of 5 years

• Xe gas time constant

  Through study completion, an average of 5 years

• Length in time of Xe MRI acquisition

  Through study completion, an average of 5 years

Study Arms (1)

Hyperpolarized 129 Xenon

EXPERIMENTAL

This research study will happen immediately following the clinical MRI exam with additional research Xe doses administered after the clinical Xe MRI procedure. Xe gas will be administered to the participant in the same manner as the clinical Xe MRI scan. Research scans without Xe gas may be acquired as well.

Drug: Hyperpolarized 129 Xenon

Interventions

Hyperpolarized 129 Xenon DRUG

The total dosing volume will be consistent with CCHMC Department of Radiology clinical standards or up to 1/6th of a participant's total lung capacity (calculated or predicted from ATS guidelines or from participant's plethysmography data if available within 6 months of MRI scan) for participants under 18 years old and 1000 milliliters for adults. No more than a total of five Xe gas doses, combined clinical and research doses, will be administered during the scanning session.

Hyperpolarized 129 Xenon

Eligibility Criteria

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

You may qualify if:

• Participant is having a clinically-ordered hyperpolarized Xe gas MRI scan

You may not qualify if:

• Pregnancy or positive pregnancy test

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

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: January 1, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: September 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)