Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT04071769
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 \<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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04071769
Study Brief:
Protocol Section:
NCT04071769