Genentech Xenon MRI Idiopathic Pulmonary Fibrosis

  • STATUS
    Recruiting
  • End date
    Mar 30, 2023
  • participants needed
    20
  • sponsor
    Duke University
Updated on 18 May 2022
ct scan
pulmonary function test
dyspnea
nintedanib
idiopathic pulmonary fibrosis
pirfenidone

Summary

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.

Details
Condition Idiopathic Pulmonary Fibrosis
Treatment Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment
Clinical Study IdentifierNCT04071769
SponsorDuke University
Last Modified on18 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Outpatients of either gender, age > 18\
Willing and able to give informed consent and adhere to visit/protocol schedules
(Consent must be given before any study procedures are performed)
Clinical diagnosis of IPF by confirmed by multidisciplinary diagnosis and naïve to treatment with an approved IPF therapy (either nintedanib or pirfenidone)

Exclusion Criteria

Subject is less than 18 years old
Subjects who have been previously on either pirfenidone or nintedanib
MRI is contraindicated based on responses to MRI screening questionnaire
Subject is pregnant or lactating
Resting oxygen saturation on room air <90% on supplemental oxygen
Respiratory illness of a bacterial or viral etiology within 30 days of MRI
Subject with ventricular cardiac arrhythmia in the past 30 days
Subject has history of cardiac arrest within the last year
Subject does not fit into 129 Xenon vest coil used for MRI
Subject deemed unlikely to be able to comply with instructions during imaging
Recent exacerbation (within 30 days) defined by the need for antibiotics and/or systemic steroids
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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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