Genentech Xenon MRI Idiopathic Pulmonary Fibrosis

Using Xenon MRI to Evaluate the Efficacy of Therapies for Idiopathic Pulmonary Fibrosis

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.

Subjects 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 subjects will have repeat studies at 3, 6 and 12 months following the initiation of therapy. Additional studies including pulmonary function studies, serum for bio markers, 6 minute walk distance and a high-resolution computed tomography (HRCT) scan (only at the 6 month visit) will be performed to determine how 129 Xenon MRI performs relative to standard of care evaluations for IPF.

The MRI uses a magnet and radio waves to make diagnostic medical images of the body. There have been no ill effects reported from exposure to the magnetism or radio waves used in this test. Risks of the xenon gas are slight numbness in legs, nausea, a feeling of well-being, and mild tingling in fingertips. You will have pulmonary function testing for the study, you may experience breathlessness or dizziness during or immediately following these tests.

Study Overview

• Status: Active, not recruiting
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Matthew P Kummerer, BSN; Phone Number: 919-668-3135; Email: matthew.kummerer@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF); 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	Drug: Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Red Blood Cell (RBC):Barrier Ratio Following Initiation of IPF Therapy	RBC:barrier ratio will be determined using 129 Xenon MRI. This ratio will be assessed in each individual prior to initiation of IPF therapy. Following initiation of therapy additional 129 Xenon MRIs will be performed at 3, 6 and 12 months. The outcome measure will be assessment of rate of RBC:barrier decline following initiation of therapy across the imaging studies from the initial 129 Xenon MRI performed prior to initiation of therapy.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pulmonary Function Following Initiation of IPF therapy	Lung function will be assessed in all subjects. This will include forced vital capacity (FVC) and diffusion capacity for carbon monoxide (DLCO). The outcome measure will be for FVC decline >10% or DLCO decline >20% over the 12 months. These measures have been identified as surrogate measures of IPF outcomes in prior clinical studies.	Pulmonary function testing will occur prior to initiation of therapy and then at 3, 6 and 12 months following initiation of therapy.

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Robert Tighe, MD, Duke University Health Systems

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Xenon
• Other Study ID Numbers: Pro00101911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No