Xenon MRI for Idiopathic Pulmonary Fibrosis

Recruiting in Palo Alto (17 mi)

Overseen byRobert Tighe, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Duke University

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is being done to determine whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments. Subjects will undergo an approximately hour long comprehensive MRI protocol, including administration of multiple doses of hyper-polarized 129 Xenon. The subjects will have this initial study prior to initiation of IPF therapies. Then the subjects will have repeat studies at 3, 6 and 12 months following the initiation of therapy. Additional studies including pulmonary function studies, serum for bio markers, 6 minute walk distance and a high-resolution computed tomography (HRCT) scan (only at the 6 month visit) will be performed to determine how 129 Xenon MRI performs relative to standard of care evaluations for IPF. The MRI uses a magnet and radio waves to make diagnostic medical images of the body. There have been no ill effects reported from exposure to the magnetism or radio waves used in this test. Risks of the xenon gas are slight numbness in legs, nausea, a feeling of well-being, and mild tingling in fingertips. You will have pulmonary function testing for the study, you may experience breathlessness or dizziness during or immediately following these tests.

Research Team

Robert Tighe, MD

Principal Investigator

Duke University Health Systems

Eligibility Criteria

This trial is for adults over 18 with a clinical diagnosis of Idiopathic Pulmonary Fibrosis (IPF) who haven't started treatment. They must be able to consent and follow the study schedule. People can't join if they don't fit in the MRI coil, have had cardiac issues or severe respiratory illness recently, are pregnant, need supplemental oxygen, or have conditions affecting their ability to participate.

Inclusion Criteria

I am over 18 years old and not hospitalized.

I have been diagnosed with IPF and have not started treatment with nintedanib or pirfenidone.

Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed)

Exclusion Criteria

I have had a heart rhythm problem in the last month.

I haven't had a lung infection in the last 30 days.

Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

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Treatment Details

Interventions

Hyperpolarized 129 Xenon Gas (Imaging Agent)

Trial OverviewThe study tests if MRI scans using hyperpolarized 129 Xenon gas can track lung function changes in IPF patients over time compared to standard treatments. Participants will undergo MRIs before starting therapy and at intervals up to one year after beginning treatment.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF)Experimental Treatment1 Intervention

Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments