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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 January 2024 |
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Main ID: |
NCT04071769 |
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Date of registration:
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09/08/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Genentech Xenon MRI Idiopathic Pulmonary Fibrosis
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Scientific title:
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Using Xenon MRI to Evaluate the Efficacy of Therapies for Idiopathic Pulmonary Fibrosis |
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Date of first enrolment:
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August 3, 2020 |
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Target sample size:
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20 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04071769 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Robert Tighe, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Duke University Health Systems |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Fibrosis
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Intervention(s)
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Drug: Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment
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Primary Outcome(s)
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Change in Red Blood Cell (RBC):Barrier Ratio Following Initiation of IPF Therapy
[Time Frame: The RBC:barrier measure will be assessed at time of study enrollment and then at 3, 6 and 12 months following initiation of IPF therapy.]
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Secondary Outcome(s)
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Change in Pulmonary Function Following Initiation of IPF therapy
[Time Frame: Pulmonary function testing will occur prior to initiation of therapy and then at 3, 6 and 12 months following initiation of therapy.]
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Secondary ID(s)
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Pro00101911
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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