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Hyperpolarized 129Xe MRI for Imaging Pulmonary Function

StatusRecruiting
PhasePhase 2
Started2011-01
View on ClinicalTrials.gov ↗

Amendment history

2026-01-14
Study Status v27
Primary completion date2025-12→2030-12
Completion date2025-12→2030-12
2025-02-04
Study Status v26
Re-verified, no change to tracked fields
2024-01-16
Study Status v25
Primary completion date2023-12→2025-12
Completion date2023-12→2025-12
2023-05-12
Study Status, Outcome Measures v24
Re-verified, no change to tracked fields
2022-10-07
Study Status v23
Primary completion date2022-12→2023-12
Completion date2022-12→2023-12
Show 22 earlier versions
2021-10-04
2 amendments v21-v22
2 re-verifications since 2021-04-22, no change to tracked fields
2021-04-13
Study Status, Conditions, Study Design, Arms and Interventions, Eligibility v20
PhasePhase 1→Phase 2
InterventionsXenon (Drug)→Hyperpolarized 129Xenon Gas (Drug)
2020-07-13
Suspended→Recruiting Study Status, Contacts/Locations v19
Trial statusSuspended→Recruiting
Reason stoppedCOVID-19→not stated
Primary completion date2020-12→2022-12
Completion date2021-12→2022-12
Study sitesdetails revised at 1 of 1 site
2020-04-23
Recruiting→Suspended Study Status, Contacts/Locations v18
Trial statusRecruiting→Suspended
Reason stoppednot stated→COVID-19
Study sitesdetails revised at 1 of 1 site
2020-01-07
2 amendments v16-v17
2 re-verifications since 2019-12-19, no change to tracked fields
2019-04-11
Study Status, Study Design v15
Enrollment target160→445
2018-10-05
2 amendments v13-v14
2 re-verifications since 2018-07-09, no change to tracked fields
2018-04-18
Study Status, Contacts/Locations v12
Study sitescontacts updated at 1 of 1 site
2017-11-30
Study Status, References v11
Publications12 to 13 entries
Robertson SH, Virgincar RS, Bier EA, He M, Schrank GM, Smigla RM, Rackley C, McAdams HP, Driehuys B. Uncovering a third dissolved-phase 129 Xe resonance in the human lung: Quantifying spectroscopic features in healthy subjects and patients with idiopathic pulmonary fibrosis. Magn Reson Med. 2017 Oct [...]
2017-08-10
2 amendments v9-v10
2 re-verifications since 2017-03-23, no change to tracked fields
2017-01-25
Study Status, References v8
Primary completion date2016-12→2020-12
Completion date2016-12→2021-12
Publications9 to 12 entries
Ebner L, He M, Virgincar RS, Heacock T, Kaushik SS, Freemann MS, McAdams HP, Kraft M, Driehuys B. Hyperpolarized 129Xenon Magnetic Resonance Imaging to Quantify Regional Ventilation Differences in Mild to Moderate Asthma: A Prospective Comparison Between Semiautomated Ventilation Defect Percentage C [...]
2016-06-16
Study Status v7
Re-verified, no change to tracked fields
2015-08-04
Study Status, References v6
Publications6 to 9 entries
Roos JE, McAdams HP, Kaushik SS, Driehuys B. Hyperpolarized Gas MR Imaging: Technique and Applications. Magn Reson Imaging Clin N Am. 2015 May;23(2):217-29. doi: 10.1016/j.mric.2015.01.003. Kaushik SS, Robertson SH, Freeman MS, He M, Kelly KT, Roos JE, Rackley CR, Foster WM, McAdams HP, Driehuys B. [...]
2015-01-16
Study Status, References v5
Publications3 to 6 entries
Kaushik SS, Cleveland ZI, Cofer GP, Metz G, Beaver D, Nouls J, Kraft M, Auffermann W, Wolber J, McAdams HP, Driehuys B. Diffusion-weighted hyperpolarized 129Xe MRI in healthy volunteers and subjects with chronic obstructive pulmonary disease. Magn Reson Med. 2011 Apr;65(4):1154-65. doi: 10.1002/mrm. [...]
2014-07-01
Study Status v4
Re-verified, no change to tracked fields
2013-12-11
Study Status, References v3
Publications1 to 3 entries
Virgincar RS, Cleveland ZI, Kaushik SS, Freeman MS, Nouls J, Cofer GP, Martinez-Jimenez S, He M, Kraft M, Wolber J, McAdams HP, Driehuys B. Quantitative analysis of hyperpolarized 129Xe ventilation imaging in healthy volunteers and subjects with chronic obstructive pulmonary disease. NMR Biomed. 201 [...]
2013-05-16
Study Status v2
Re-verified, no change to tracked fields
2012-11-13
Study Status, Sponsor/Collaborators v1
Lead sponsorDuke University→Bastiaan Driehuys
2011-01-20
Original filing
The purpose of this study is to develop and evaluate the usefulness of MRI using 129Xe gas for regional assessment of pulmonary function. Specifically, three forms of 129Xe MRI contrast will be the investigators focus - 1) imaging of the 129Xe ventilation distribution, 2) imaging the alveolar microstructure via the 129Xe apparent diffusion coefficient (ADC), and 3) imaging 129Xe that dissolves in the pulmonary blood and tissues upon inhalation. Such imaging of 129Xe gas transfer is expected to be uniquely sensitive to pathologies affecting gas exchange (fibrosis, emphysema, pulmonary hypertension) and provide new insights regarding the normal resting heterogeneity of pulmonary gas exchange.
Trial Details
NCT Number NCT01280994
Lead Sponsor Bastiaan Driehuys
Conditions Interstitial Lung Disease
Enrollment 445 participants
Start Date 2011-01
Primary Completion 2030-12 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-16