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.

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.

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 (Actual): 34
• Phase: Phase 2

Contacts and Locations

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
Efficiency of Gas Exchange as Measured by the Red Blood Cell (RBC):Barrier Ratio Following Initiation of IPF Therapy	RBC:barrier ratio will be determined using 129 Xenon MRI. The RBC:barrier ratio is a key metric that quantifies the efficiency of gas exchange, specifically the balance between red blood cell uptake and alveolar-capillary barrier function by showing how well oxygen gets from the air sacs to the blood. A low ratio often indicates impaired gas transfer, reflecting conditions where either RBC function or the barrier's permeability is compromised.	Baseline, 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 - Forced Vital Capacity (FVC)	FVC, or Forced Vital Capacity, is a lung function test that measures the maximum amount of air a person can forcefully exhale from their lungs after taking a deep breath. This test is performed using a spirometer and the results are used by healthcare providers to help diagnose and monitor pulmonary diseases like asthma, emphysema, or restrictive lung conditions.	Baseline, 3, 6, and 12 months following initiation of IPF therapy
Change in Pulmonary Function Following Initiation of IPF Therapy - Diffusion Capacity for Carbon Monoxide (DLCO)	The DLCO, or Diffusing Capacity of the Lung for Carbon Monoxide, is a pulmonary function test that measures how well oxygen transfers from the lungs to the blood by measuring how much carbon monoxide diffuses from the lungs into the bloodstream. Performed by inhaling a special gas mixture and holding the breath, the DLCO test assesses the gas exchange function of the lungs.	Baseline, 3, 6, and 12 months following initiation of IPF 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 (Actual): October 17, 2024
• Study Completion (Estimated): September 30, 2029

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 (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Anesthetics, General; Anesthetics, Inhalation; Therapeutics
• 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
• product manufactured in and exported from the U.S.: No