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Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hyperpolarized Xenon-129 MRI (Experimental)
Radioactive Xenon-133 scintigraphy (Active Comparator)
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Virginia Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

COPD patients - Xe-133

COPD patients - Hyperpolarized Xe-129

Arm Description

COPD patients who will be assessed with Xenon-133 scintigraphy (Standard diagnostic study)

COPD patients crossed over from the Active Comparator Arm who will be assessed with hyper polarized Xenon-129 MRI (Experimental diagnostic study)

Outcomes

Primary Outcome Measures

Ventilation imaging resolution comparison between MRI and scintigraphy
Compare the quality of the imaging between hyper polarized xenon-129 and radioactive xenon-133

Secondary Outcome Measures

Full Information

First Posted
October 31, 2017
Last Updated
November 2, 2020
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT03331302
Brief Title
Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy
Official Title
Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Model Description
COPD patients with standard vs study diagnostic methods (imaging procedures)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COPD patients - Xe-133
Arm Type
Active Comparator
Arm Description
COPD patients who will be assessed with Xenon-133 scintigraphy (Standard diagnostic study)
Arm Title
COPD patients - Hyperpolarized Xe-129
Arm Type
Experimental
Arm Description
COPD patients crossed over from the Active Comparator Arm who will be assessed with hyper polarized Xenon-129 MRI (Experimental diagnostic study)
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized Xenon-129 MRI (Experimental)
Other Intervention Name(s)
Polarean Pilot study
Intervention Description
MRI ventilation scan of the lung with inhaled contrast agent (hyperpolarized Xenon-129)
Intervention Type
Drug
Intervention Name(s)
Radioactive Xenon-133 scintigraphy (Active Comparator)
Other Intervention Name(s)
Pilot study
Intervention Description
Radioactive ventilation scintigraphy of the lung with inhaled radioactive contrast agent (Xenon-133)
Primary Outcome Measure Information:
Title
Ventilation imaging resolution comparison between MRI and scintigraphy
Description
Compare the quality of the imaging between hyper polarized xenon-129 and radioactive xenon-133
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Struchen, RN
Phone
4342436074
Email
SS8YM@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Roselove Nunoo-Asare, RT
Phone
4342437363
Email
RNN3B@hscmail.mcc.virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun M Shim, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Struchen, RN
Phone
434-243-6074
Email
SS8YM@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Roselove Nunoo-Asare, RT
Phone
434-243-6074
Email
RNN3B@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Mike Shim, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided for now.

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Hyper Polarized Xenon-129 MRI vs Xenon-133 Scintigraphy

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