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Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy

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: NCT03331302
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Y. Michael Shim, MD, University of Virginia

Brief Summary:
Hyper polarized Xenon-129 MRI will be directly compared to a radioactive Xe-133 scintigraphy to detect defects in lung ventilation from airflow limitation. This study is conducted as a pilot study with intention to conduct a larger clinical trial.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Hyperpolarized Xenon-129 MRI (Experimental) Drug: Radioactive Xenon-133 scintigraphy (Active Comparator) Phase 1 Phase 2

Detailed Description:
Hyperpolarized Xenon-129 MRI has been developed by a number of techniques for imaging the lung that provide information about various aspects of lung function and structure. The main objective of this pilot study is to test and optimize the imaging parameters for a future industry sponsored clinical trial. The goal of the future trial is to determine the concordance between hyperpolarized xenon-129 ventilation MR imaging and nuclear medicine ventilation imaging (Gold Standard). In this study we will test the imaging parameters and techniques. We will directly compare human ventilation lung images in subjects with COPD, using nuclear medicine ventilation imaging with Xenon-133 gas scintigraphy versus hyperpolarized xenon-129 gas MRI. Our hypothesis is that current Xe-133 scintigraphy, which uses a radioactive gas (Xe-133) and produces a projection image of the lungs with relatively poor resolution, will not be able to detect small lung ventilation obstructions, which can be detected using hyperpolarized Xe-129 gas MRI.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: COPD patients with standard vs study diagnostic methods (imaging procedures)
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
Active Comparator: COPD patients - Xe-133
COPD patients who will be assessed with Xenon-133 scintigraphy (Standard diagnostic study)
Drug: Radioactive Xenon-133 scintigraphy (Active Comparator)
Radioactive ventilation scintigraphy of the lung with inhaled radioactive contrast agent (Xenon-133)

Experimental: COPD patients - Hyperpolarized Xe-129
COPD patients crossed over from the Active Comparator Arm who will be assessed with hyper polarized Xenon-129 MRI (Experimental diagnostic study)
Drug: Hyperpolarized Xenon-129 MRI (Experimental)
MRI ventilation scan of the lung with inhaled contrast agent (hyperpolarized Xenon-129)




Primary Outcome Measures :
  1. Ventilation imaging resolution comparison between MRI and scintigraphy [ Time Frame: 12 months ]
    Compare the quality of the imaging between hyper polarized xenon-129 and radioactive xenon-133



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have a diagnosis of COPD
  • at their clinical baseline on the day of imaging
  • must be clinically stable in order to participate in the study.
  • COPD subjects will be categorized according to the GOLD
  • Current/Former SmokerSubjects
  • must have a smoking history ≥ 10 pack years

Exclusion Criteria:

  • Dx of asthma
  • Continuous oxygen use at home
  • Blood oxygen saturation of 92% less than as measured by pulse oximetry on the day of imaging
  • FEV1 percent predicted less than 25%
  • Pregnancy or lactation
  • Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning
  • Subjects with any implanted device that cannot be verified as MRI compliant will be excluded
  • Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches
  • History of congenital cardiac disease, chronic renal failure, or cirrhosis
  • Inability to understand simple instructions or to hold still for approximately 10 seconds
  • History of respiratory infection within 2 weeks prior to the MR scan
  • History of MI, stroke and/or poorly controlled hypertension.

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): NCT03331302


Contacts
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Contact: Sarah Struchen, RN 4342436074 SS8YM@hscmail.mcc.virginia.edu
Contact: Roselove Nunoo-Asare, RT 4342437363 RNN3B@hscmail.mcc.virginia.edu

Locations
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United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Sarah Struchen, RN    434-243-6074    SS8YM@hscmail.mcc.virginia.edu   
Contact: Roselove Nunoo-Asare, RT    434-243-6074    RNN3B@hscmail.mcc.virginia.edu   
Principal Investigator: Mike Shim, MD         
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Yun M Shim, MD University of Virginia

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Responsible Party: Y. Michael Shim, MD, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT03331302    
Other Study ID Numbers: 20053
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided for now.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs