Status:
ACTIVE_NOT_RECRUITING
Genentech Xenon MRI Idiopathic Pulmonary Fibrosis
Lead Sponsor:
Duke University
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ov...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2029
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04071769
Start Date
August 3 2020
End Date
September 30 2029
Last Update
January 2 2026
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710