Gas Exchange MRI to Visualize Regional Therapy Response in Interstitial Lung Disease

NCT06012500 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 2021-0031
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this multi-centered, NIH-sponsored study is to to develop an optimal protocol for using non-invasive 129Xe gas exchange MRI to detect changing disease activity in interstitial lung diseases (ILDs). We base this study on the demonstrated promise of 129Xe as a biomarker for both prognosis and therapy response, overwhelming interest from both industry and academic partners, and impending FDA approval for 129Xe ventilation MRI. This requires disseminating standardized and repeatable methods for 3D 129Xe functional MRI in order to facilitate innovative multi-center observational and interventional trials that can advance our understanding of fibrotic lung disease, while accelerating the development of novel therapies.

Conditions

ILD

Outcome Measures

Primary Outcomes (3)

• Maximize and Measure Repeatability of 129Xe MRI/MRS Metrics across MRI Platforms

  Harmonize MRI/MRS protocols by improved coaching, optimized dose delivery, and tailoring the inhaled dose volume to the individual patient. Using these approaches, each center will demonstrate coefficients of repeatability of ±6% or better in patients with ILD.

  1 day

• Establish Harmonized Quantitative Analysis of Gas Exchange MRI/MRS

  Deploy a reconstruction and analysis package enabling users of any of three major MRI vendor platforms to obtain robust, real-time quantitative analysis of images and spectra.

  1 day

• Deploy a Clinical Framework to Identify Active Fibrosis and Normal Aging

  To position the technology for clinical deployment and interpretation, we will develop a physiologic model incorporating ventilation, barrier and RBC metrics to explain the underlying factors responsible for a given patient's diffusing capacity (DLCO) and transfer coefficient (KCO)

  1 Day

Study Arms (1)

Hyperpolarized 129 Xenon

EXPERIMENTAL

Hyperpolarized xenon gas will be administered in 20% of each subject's forced vital capacity (FVC) with up to 1000 milliliters of xenon being given to a participant followed by a breath hold of up to 16 seconds

Drug: Xenon-129

Interventions

Xenon-129 DRUG

Inhaled contrast for MRI

Hyperpolarized 129 Xenon

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients age 18 - 90 years old.
• Subject has no diagnosed pulmonary conditions
• Subject has not smoked in the previous 5 years
• Smoking history, if any, is less than or equal to 5 pack-years
• Subject has a regular 26-30-day menstrual cycle
• Subject is taking prescribed hormonal contraceptives that preserve a regular menstrual cycle.

You may not qualify if:

• MRI is contraindicated based on responses to MRI screening questionnaire
• Subject is pregnant or lactating
• Resting oxygen saturation on room air \<90%
• Respiratory illness of a bacterial or viral etiology within 30 days of MRI
• Subject has history of any known severe ventricular cardiac arrhythmia, as determined by the study physician.
• Subject has history of cardiac arrest within the last year
• Subject cannot hold their breath for 16 seconds

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Interventions

Xenon-129

Study Officials

• Zack Cleveland, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

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 3, 2021
• First Posted: August 25, 2023
• Study Start: April 14, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)