Genentech Xenon MRI Idiopathic Pulmonary Fibrosis

NCT ID: NCT04071769

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-03
• Study Completion Date: 2029-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Bastiaan Driehuys

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Tighe, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University Health Systems

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00101911

Identifier Type: -

Identifier Source: org_study_id