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Hyperpolarized 129Xe MRI of Survivors of COVID-19

Primary Purpose

Covid19

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hyperpolarized Xe129
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid19

Eligibility Criteria

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

Inclusion Criteria:

  • Oxygenation saturation of ≥88% at rest by study staff within 48 hours prior to study entry.
  • The participant has a previous diagnosis of COVID-19 confirmed by COVID-19 PCR or antibody testing and is being seen for outpatient follow-up.
  • Subject is at least 10 days post-symptom-onset and do not have a fever (<99.5°).
  • Ability to read and understand English or Spanish

Exclusion Criteria:

  • Subject is less than 18 years old
  • MRI is contraindicated based on responses to MRI screening questionnaire
  • Subject is pregnant or lactating
  • Subject does not fit into 129Xe vest coil used for MRI
  • Subject cannot hold his/her breath for 15-16 seconds
  • Subject deemed unlikely to be able to comply with instructions during imaging
  • Oxygen saturation <88% on room air or with supplemental oxygen
  • Cognitive deficits that preclude ability to provide consent
  • Institutionalization

Sites / Locations

  • University of Kansas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COVID-19 Survivors

Arm Description

Subjects recovering from COVID-19 disease will be imaged using hyperpolarized 129Xe MRI.

Outcomes

Primary Outcome Measures

Ventilation Defect Percentage
VDP at Baseline
Ventilation Defect Percentage
VDP at 6 months

Secondary Outcome Measures

Full Information

First Posted
December 7, 2020
Last Updated
August 29, 2022
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04659707
Brief Title
Hyperpolarized 129Xe MRI of Survivors of COVID-19
Official Title
Evaluating Lung Structure and Function in Survivors of COVID-19 Using Hyperpolarized 129Xe MRI
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center

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
The purpose of this study is to evaluate pulmonary function of patients recovering from mild, moderate, and severe COVID-19 disease using hyperpolarized 129Xe MRI.
Detailed Description
COVID-19, the disease at the heart of the current global pandemic, is characterized by fevers, cough, sore throat, malaise, and myalgias, with 98% of patients experiencing some pulmonary involvement. In those infected with the causative virus, SARS-CoV-2, the severity of symptoms, as well as their duration, is widely variable. There is strong evidence from computed tomography (CT) images of patients with severe COVID-19 that pulmonary abnormalities and lung damage caused by infection may have long-term consequences for survivors. Furthermore, many patients with mild or moderate experience symptoms such as fatigue and dyspnea long (>60 days) after initial symptom onset, but there are currently no clinical predictors of which patients are at greatest risk for long-term health effects. As such, sensitive and specific predictors or biomarkers that can evaluate quality-of-life, risk of infection exacerbation, and long-term outcomes are critically needed. Pulmonary imaging using hyperpolarized (HP) 129Xe magnetic resonance imaging (MRI) provides a means to detect abnormalities in the pulmonary small airways, vasculature, and parenchyma by quantifying pulmonary ventilation, gas diffusion, and regional gas exchange. HP 129Xe MRI is fast (<16s), non-invasive, and radiation free, making it a safe and effective method for characterizing lung function, even in individuals with lung disease. In this pilot study, we will use HP 129Xe to evaluate pulmonary structure and function in COVID-19 patients using the following specific aims: Aim 1. Detect regional pulmonary function abnormalities in recovering COVID-19 patients using hyperpolarized 129Xe MRI. The hypothesis is that ventilation and gas exchange defects will be present in recovering COVID-19 patients, and further that the extent of impairment will correlate with disease severity. Aim 2. Determine risk factors for long term outcomes using hyperpolarized 129Xe MRI and clinical biomarkers. The hypothesis is that HP 129Xe MRI biomarkers will predict long-term lung function impairment brought on by COVID-19. These aims will be tested by performing HP 129Xe MRI in patients recovering from mild, moderate, or severe COVID-19. By coming to a fuller understanding of the long-term impairment of pulmonary function, future treatment can be optimized to minimize severe disease and health care utilization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 Survivors
Arm Type
Experimental
Arm Description
Subjects recovering from COVID-19 disease will be imaged using hyperpolarized 129Xe MRI.
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized Xe129
Other Intervention Name(s)
HP Xenon, 129Xe
Intervention Description
Subjects will inhale up to 4 doses of hyperpolarized Xenon gas in order to image pulmonary function.
Primary Outcome Measure Information:
Title
Ventilation Defect Percentage
Description
VDP at Baseline
Time Frame
Baseline
Title
Ventilation Defect Percentage
Description
VDP at 6 months
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Oxygenation saturation of ≥88% at rest by study staff within 48 hours prior to study entry. The participant has a previous diagnosis of COVID-19 confirmed by COVID-19 PCR or antibody testing and is being seen for outpatient follow-up. Subject is at least 10 days post-symptom-onset and do not have a fever (<99.5°). Ability to read and understand English or Spanish Exclusion Criteria: Subject is less than 18 years old MRI is contraindicated based on responses to MRI screening questionnaire Subject is pregnant or lactating Subject does not fit into 129Xe vest coil used for MRI Subject cannot hold his/her breath for 15-16 seconds Subject deemed unlikely to be able to comply with instructions during imaging Oxygen saturation <88% on room air or with supplemental oxygen Cognitive deficits that preclude ability to provide consent Institutionalization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter J Niedbalski, PhD
Phone
9135882271
Email
pniedbalski@kumc.edu
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter J Niedbalski, PhD
Phone
913-588-2271
Email
pniedbalskI@kumc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified imaging data will be shared with researchers upon reasonable request.

Learn more about this trial

Hyperpolarized 129Xe MRI of Survivors of COVID-19

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