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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: ILD

In brief

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.

Key facts

Study ID: NCT06012500
Run by: Children's Hospital Medical Center, Cincinnati
People needed: 78
Starts: 2022-04-14
Expected to finish: 2027-12-30
Last updated by the study team: 2026-02-13

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

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
Additional inclusion criteria for menstruation sub-study in healthy volunteers
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

Where it is running

Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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