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Completed
NCT04071769
Genentech Xenon MRI Idiopathic Pulmonary Fibrosis
Conditions: Idiopathic Pulmonary Fibrosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 34
Sponsor: Duke University
Location: Duke University Medical Center Durham North Carolina
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.
Participants 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 participants will have repeat studies at 3, 6 and 12 months following the initiation of therapy.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT04071769). StuddyBuddy aggregates publicly available trial information.