Genentech Xenon MRI Idiopathic Pulmonary Fibrosis

NCT04071769 | Active Not Recruiting Phase 2 Results FDA Drug

• 1 other identifier: Pro00101911
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Pulmonary Function Following Initiation of IPF Therapy - Forced Vital Capacity (FVC)

  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)

  Baseline, 3, 6, and 12 months following initiation of IPF therapy

Study Arms (1)

Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF)

EXPERIMENTAL

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

Interventions

Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment DRUG

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

Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Robert M. Tighe, MD
• Organization: Duke University

robert.tighe@duke.edu

919-684-4894

Study Officials

• Robert Tighe, MD

  Duke University Health Systems

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 28, 2019
• Study Start: August 3, 2020
• Primary Completion: October 17, 2024
• Study Completion (Estimated): September 30, 2029
• Last Updated: January 2, 2026
• Results First Posted: January 2, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)