Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04071769

Genentech Xenon MRI 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Efficiency of Gas Exchange as Measured by the Red Blood Cell (RBC):Barrier Ratio Following Initiation of IPF Therapy

    Time frame: Baseline, 3, 6, and 12 months 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.

Secondary outcomes

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

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

    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.

  2. Change in Pulmonary Function Following Initiation of IPF Therapy - Diffusion Capacity for Carbon Monoxide (DLCO)

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

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2029
First posted
Aug 28, 2019
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.