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Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy

Sponsor
University of Virginia (Other)
Overall Status
Recruiting
CT.gov ID
NCT03331302
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
28
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
COPD patients with standard vs study diagnostic methods (imaging procedures)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 :
Sep 1, 2018
Actual Primary Completion Date :
Jun 30, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

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)
Other Names:
  • Pilot study

    		•
    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)
    Other Names:
  • Polarean Pilot study

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ventilation imaging resolution comparison between MRI and scintigraphy [12 months]

      Compare the quality of the imaging between hyper polarized xenon-129 and radioactive xenon-133

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Virginia Health System Charlottesville Virginia United States 22908

    Sponsors and Collaborators

    • University of Virginia

    Investigators

    • Principal Investigator: Yun M Shim, MD, University of Virginia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Y. Michael Shim, MD, Associate Professor, University of Virginia
    ClinicalTrials.gov Identifier:
    NCT03331302
    Other Study ID Numbers:
    • 20053
    First Posted:
    Nov 6, 2017
    Last Update Posted:
    Nov 4, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive
    Xenon

    Study Results

    No Results Posted as of Nov 4, 2020