drugset / Trial / NCT06012500

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

NCT06012500

Phase 1/2 Active not recruiting 78 enrolled Children's Hospital Medical Center, Cincinnati
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2022-04-14
Primary completion
2026-12-01
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Xenon-129 Diagnostic / imaging agent 1000 ml Inhaled