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Using MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT02478268
Recruitment Status : Recruiting
First Posted : June 23, 2015
Last Update Posted : May 15, 2019
Sponsor:
Collaborators:
University of Wisconsin, Madison
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Bastiaan Driehuys, Duke University

Tracking Information
First Submitted Date  ICMJE June 16, 2015
First Posted Date  ICMJE June 23, 2015
Last Update Posted Date May 15, 2019
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02478268 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2015)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary Fibrosis
Official Title  ICMJE Using MRI to Visualize Regional Therapy Response in Idiopathic Pulmonary Fibrosis
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Patients with idiopathic pulmonary fibrosis
    Interventions:
    • Drug: Hyperpolarized 129-Xenon gas
    • Device: MRI
  • Active Comparator: Healthy volunteers
    Interventions:
    • Drug: Hyperpolarized 129-Xenon gas
    • Device: MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2015)
79
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Samantha Womack, MS 919-684-7931 sam.womack@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02478268
Other Study ID Numbers  ICMJE Pro00060259
R01HL126771 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bastiaan Driehuys, Duke University
Study Sponsor  ICMJE Bastiaan Driehuys
Collaborators  ICMJE
  • University of Wisconsin, Madison
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
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
PRS Account Duke University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP