NCT04071769CompletedPhase 2
Genentech Xenon MRI Idiopathic Pulmonary Fibrosis
Using Xenon MRI to Evaluate the Efficacy of Therapies for Idiopathic Pulmonary Fibrosis
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 9 Aug 2019
- Start date
- 3 Aug 2020
- Primary completion date
- 17 Oct 2024
- Lead sponsor
- Duke University
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT04071769
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 34
- From 3 Aug 2020 to the primary completion date, 17 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who have been previously on either pirfenidone or nintedanib
- Recent exacerbation (within 30 days) defined by the need for antibiotics and/or systemic steroids
Other illness
- 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
- 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
Age
- Subject is less than 18 years old
Other
- 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
- Subject does not fit into 129 Xenon vest coil used for MRI
- Subject deemed unlikely to be able to comply with instructions during imaging
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.