Design and Implementation of a Multi-Center Trial of 129 Xe Gas Exchange MRI and MRS to Evaluate Longitudinal Progression of COPD

Bastiaan Driehuys; Shuo Zhang; Aryil Bechtel; Andrew D Hahn; Guilhem Collier; Peter J Niedbalski; Yuh-Chin Huang; Zackary I Cleveland; Matthew M Willmering; John P Mugler III; Jaime Mata; Yun Michael Shim; Mario Castro; Sarah Svenningsen; Yonni Friedlander; Terence Ho; Sean Fain; Eric A Hoffman; Jim M Wild; Robert P Thomen; Talissa Altes; Ummul Afia Shammi; Will Harris; Yixuan Zou; Alexandre Fernandez Coimbra; Paula Belloni; Laura C Bell; David Mummy

doi:10.1002/jmri.29769

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Design and Implementation of a Multi-Center Trial of 129 Xe Gas Exchange MRI and MRS to Evaluate Longitudinal Progression of COPD

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Design and Implementation of a Multi-Center Trial of 129 Xe Gas Exchange MRI and MRS to Evaluate Longitudinal Progression of COPD

Bastiaan Driehuys, Shuo Zhang, Aryil Bechtel, Andrew D Hahn, Guilhem Collier, Peter J Niedbalski, Yuh-Chin Huang, Zackary I Cleveland, Matthew M Willmering, John P Mugler III, …

Journal of magnetic resonance imaging, Vol.62(6), pp.1879-1891

12/2025

DOI: 10.1002/jmri.29769

PMCID: PMC12353566

PMID: 40266001

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Abstract

MR imaging holds the potential to enhance drug development efficiency by de-risking early phase studies and increasing confidence in results. It can improve patient selection, increase repeatability, and provide greater sensitivity to change, thereby enabling smaller, faster clinical trials. For trials in the pulmonary space, hyperpolarized Xe MRI is appealing because it provides 3-dimensional imaging of pulmonary ventilation and gas exchange in a brief, non-invasive exam. Metrics derived from Xe MRI may be more sensitive to disease progression than conventional lung function assessments and may thus provide a valuable means to evaluate numerous novel pharmacologic and biologic therapies now in development. However, despite the acute need for better patient selection and for prognostic and monitoring biomarkers, Xe MR imaging is not yet widely utilized in pulmonary drug development, partly because such trials must be conducted at multiple centers to enroll enough participants. Thus, incorporating Xe MRI requires broader dissemination, harmonized image acquisition protocols, standardized dose delivery, visualization, and quantification. Multi-site trials must also be able to operate across all major MRI vendor platforms and diverse software/hardware revisions. To this end, the Xe MRI Clinical trials consortium has published a harmonized protocol describing four recommended acquisitions. Here we report on the first industry-sponsored study to deploy this Xe MRI/MRS protocol in a multi-center, multi-platform, multi-national study to evaluate longitudinal progression of chronic obstructive pulmonary disease (COPD). We demonstrate the steps necessary to implement standardized Xe-MRI acquisition techniques across multiple sites and discuss the practices implemented, quality control approaches, and lessons learned for facilitating and accelerating the implementation of future trials that incorporate this technology. Level of Evidence: 5.

129Xe MRI

guidelines

longitudinal

chronic obstructive pulmonary disease

Details

Title: Subtitle: Design and Implementation of a Multi-Center Trial of 129 Xe Gas Exchange MRI and MRS to Evaluate Longitudinal Progression of COPD
Creators: Bastiaan Driehuys - Duke University
Shuo Zhang - Duke Medical Center
Aryil Bechtel - Duke University
Andrew D Hahn - University of Iowa
Guilhem Collier - University of Sheffield
Peter J Niedbalski - University of Kansas Medical Center
Yuh-Chin Huang - Duke University
Zackary I Cleveland - University of Cincinnati
Matthew M Willmering - University of Cincinnati
John P Mugler III - University of Virginia
Jaime Mata - University of Virginia
Yun Michael Shim - University of Virginia
Mario Castro - University of Kansas Medical Center
Sarah Svenningsen - St. Joseph’s Healthcare Hamilton
Yonni Friedlander - St. Joseph’s Healthcare Hamilton
Terence Ho - St. Joseph’s Healthcare Hamilton
Sean Fain - Department of Radiology, University of Iowa, Iowa City, Iowa, USA
Eric A Hoffman - University of Iowa
Jim M Wild - University of Sheffield
Robert P Thomen - University of Missouri
Talissa Altes - University of Missouri
Ummul Afia Shammi - University of Illinois Chicago
Will Harris - Genentech
Yixuan Zou - Genentech
Alexandre Fernandez Coimbra - Genentech
Paula Belloni - Genentech
Laura C Bell - Genentech
David Mummy - Duke University
Resource Type: Journal article
Publication Details: Journal of magnetic resonance imaging, Vol.62(6), pp.1879-1891
DOI: 10.1002/jmri.29769
PMID: 40266001
PMCID: PMC12353566
NLM abbreviation: J Magn Reson Imaging
ISSN: 1053-1807
eISSN: 1522-2586
Publisher: Wiley; HOBOKEN
Grant note: Genentech R01HL105643 / NIH HHS R01HL168446 / NIH HHS 1S10OD026960 / NIH HHS R01HL126771 / NIH HHS
Language: English
Electronic publication date: 04/23/2025
Date published: 12/2025
Academic Unit: Roy J. Carver Department of Biomedical Engineering; Radiology; Electrical and Computer Engineering; Health, Sport, and Human Physiology ; Internal Medicine
Record Identifier: 9984813155602771

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