ClinicalTrials.gov
ClinicalTrials.gov Menu

Using MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02478268
Recruitment Status : Recruiting
First Posted : June 23, 2015
Last Update Posted : July 11, 2018
Sponsor:
Collaborators:
University of Wisconsin, Madison
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Bastiaan Driehuys, Duke University

Brief Summary:

The purpose of this study is to determine whether magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, and conventional contrast can help visualize impaired lung function and detect changes over time in patients receiving treatment as well as those who don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be able to show areas of abnormal thickening of parts of the lungs. These images combined with images taken with injected contrast agents or other types of MRI may provide a better way to look at lung structure and function in patients with IPF. The ultimate goal is to predict how a particular patient might respond to a particular therapy and to observe such responses earlier than conventional tests. The investigators anticipate that the images acquired in this study will provide more specific information about lung disease than standard lung function tests. The use of 129Xe MRI is investigational. "Investigational" means that these tests have not yet been approved by the US Food and Drug Administration and are being tested in research studies like this one. In addition, standard MRI with contrast is not typically done as standard of care for monitoring progression of IPF, therefore, its use in this study is also considered investigational.

Healthy volunteers are being asked to participate in this study because the investigators need to develop a database of functional images that are representative of healthy lungs.


Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Hyperpolarized 129-Xenon gas Device: MRI Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 79 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Using MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary Fibrosis
Study Start Date : May 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
Active Comparator: Patients with idiopathic pulmonary fibrosis Drug: Hyperpolarized 129-Xenon gas
Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject TLC followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
Other Name: Hyperpolarized 129Xe

Device: MRI
Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.

Active Comparator: Healthy volunteers Drug: Hyperpolarized 129-Xenon gas
Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject TLC followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
Other Name: Hyperpolarized 129Xe

Device: MRI
Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.




Primary Outcome Measures :
  1. Change in lung function as measured by ventilation defect percentage (VDP) [ Time Frame: 12 months ]
    We expect that 129Xe ventilation defect percentage, and 129Xe ventilated lung volume measured 3 months after baseline, will predict CT progression observed 12 months from baseline


Secondary Outcome Measures :
  1. Change in lung function as measured by gas exchange defect percentage (EDP) [ Time Frame: 12 months ]
    Although the study is powered on ventilation defect percentage, we expect regional gas exchange defects to be a more sensitive marker of progression



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy volunteer (technical optimization)
  2. Outpatients of either gender, age > 18.
  3. Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.)
  4. Clinical diagnosis of IPF by established means

Exclusion Criteria:

  1. Subject is less than 18 years old
  2. MRI is contraindicated based on responses to MRI screening questionnaire
  3. Subject is pregnant or lactating
  4. Respiratory illness of a bacterial or viral etiology within 30 days of MRI
  5. Subject has any form of known cardiac arrhythmia
  6. Subject does not fit into 129Xe vest coil used for MRI
  7. Subject cannot hold his/her breath for 15 seconds
  8. Subject deemed unlikely to be able to comply with instructions during imaging
  9. Recent exacerbation (within 30 days) defined by the need for antibiotics and/or systemic steroids
  10. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02478268


Contacts
Contact: Samantha Womack, MS 919-684-7931 sam.womack@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27713
Contact: Samantha Womack, MS    919-684-7931    sam.womack@duke.edu   
Contact: Jennifer Korzekwinski    919-681-7362    jennifer.korzekwinski@duke.edu   
United States, Wisconsin
University of Wisconsin Madison Recruiting
Madison, Wisconsin, United States, 53792
Contact: Molly Ellertson, R.N.    608-417-0037    Mellertson@uwhealth.org   
Contact: Sean B Fain, Ph.D.    (608) 263-0090    sfain@wisc.edu   
Principal Investigator: Sean B Fain, Ph.D.         
Sponsors and Collaborators
Bastiaan Driehuys
University of Wisconsin, Madison
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Joseph Mammarappallil, M.D. Duke University
Study Director: Bastiaan Driehuys, Ph.D. Duke University
Study Director: Sean B Fain, Ph.D. University of Wisconsin, Madison

Responsible Party: Bastiaan Driehuys, Associate Professor of Radiology, Duke University
ClinicalTrials.gov Identifier: NCT02478268     History of Changes
Other Study ID Numbers: Pro00060259
R01HL126771 ( U.S. NIH Grant/Contract )
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018

Keywords provided by Bastiaan Driehuys, Duke University:
idiopathic pulmonary fibrosis
xenon gas

Additional relevant MeSH terms:
Lung Diseases, Interstitial
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs