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Hyperpolarized 129Xe MRI for Imaging Pulmonary Function in Lung Disease

Phase 2

Recruiting

Led By Joseph Mammarappallil, M.D.

Research Sponsored by Bastiaan Driehuys

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has not smoked in the previous 5 years

Inclusion Criteria for Subjects with lung disease: Subject has a diagnosis of pulmonary dysfunction made by a physician

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 2

Awards & highlights

Study Summary

This trial is testing if MRI can be used to assess how well someone's lungs are working, by looking at how gases move in the lungs.

Who is the study for?

This trial is for adults with stable lung function who haven't had a worsening of their condition in the last month. Smokers can join if they've smoked 5 or fewer pack-years. There's also a group for healthy people without lung issues and who haven't smoked in 5 years.Check my eligibility

What is being tested?

The study is testing MRI scans using a special gas called Hyperpolarized Xenon-129 to see how well different parts of the lungs are working, looking at air distribution, tiny air sacs (alveoli), and how gas transfers into blood and tissues.See study design

What are the potential side effects?

Since this trial involves MRI imaging with an inhaled gas, there may be minimal side effects such as discomfort from holding breath during scanning or mild dizziness from inhaling the gas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not smoked in the last 5 years.

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I have been diagnosed with lung disease by a doctor.

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My breathing has not gotten worse in the last month.

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I do not have any lung diseases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bastiaan DriehuysLead Sponsor

14 Previous Clinical Trials

636 Total Patients Enrolled

Joseph Mammarappallil, M.D.Principal InvestigatorDuke University

2 Previous Clinical Trials

89 Total Patients Enrolled

Media Library

Treatment Clinical Trial Eligibility Overview. Trial Name: NCT01280994 — Phase 2

Interstitial Lung Disease Research Study Groups:

Interstitial Lung Disease Clinical Trial 2023: Treatment Highlights & Side Effects. Trial Name: NCT01280994 — Phase 2

Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT01280994 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being recruited for this experiment?

"Affirmative, there is an ongoing recruitment effort for this clinical trial. As noted on clinicaltrials.gov, the original posting date was January 1st 2011 and it was most recently updated October 7th 2022. 445 participants are required from a single site to complete the study."

Answered by AI

Is this medical experiment currently recruiting participants?

"The information on clinicaltrials.gov suggests that this medical experiment is seeking participants; it was first made available in January 2011 and its details were most recently modified in October 2022."

Answered by AI

Has this treatment received official sanction from the FDA?

"We have assigned a rating of 2 to the safety profile of this treatment as it is currently in Phase 2 trials, meaning that while there are indications of safety, efficacy has yet to be established."

Answered by AI

Recent research and studies

Journal of Applied PhysiologyJournal

Probing the Regional Distribution of Pulmonary Gas Exchange Through Single-breath Gas- and Dissolved-phase 129xe MR Imaging

Kaushik, S. Sivaram, Matthew S. Freeman, Zackary I. Cleveland, John Davies, Jane Stiles, Rohan S. Virgincar, Scott H. Robertson, et al.. 2013. “Probing the Regional Distribution of Pulmonary Gas Exchange Through Single-breath Gas- and Dissolved-phase 129xe MR Imaging”. Journal of Applied Physiology. American Physiological Society. doi:10.1152/japplphysiol.00092.2013.

Magnetic Resonance ImagingJournal

Dose and Pulse Sequence Considerations for Hyperpolarized 129xe Ventilation MRI

He, Mu, Scott H. Robertson, S. Sivaram Kaushik, Matthew S. Freeman, Rohan S. Virgincar, John Davies, Jane Stiles, William M. Foster, H. Page McAdams, and Bastiaan Driehuys. 2015. “Dose and Pulse Sequence Considerations for Hyperpolarized 129xe Ventilation MRI”. Magnetic Resonance Imaging. Elsevier BV. doi:10.1016/j.mri.2015.04.005.

NMR in BiomedicineJournal

Quantitative Analysis of Hyperpolarized 129 Xe Ventilation Imaging in Healthy Volunteers and Subjects with Chronic Obstructive Pulmonary Disease

Virgincar, Rohan S., Zackary I. Cleveland, S. Sivaram Kaushik, Matthew S. Freeman, John Nouls, Gary P. Cofer, Santiago Martinez-Jimenez, et al.. 2012. “Quantitative Analysis of Hyperpolarized 129 Xe Ventilation Imaging in Healthy Volunteers and Subjects with Chronic Obstructive Pulmonary Disease”. NMR in Biomedicine. Wiley. doi:10.1002/nbm.2880.

Journal of Applied PhysiologyJournal