Hyperpolarized Xe129 MRI for COVID-19

Overseen By Peter J Niedbalski, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Kansas Medical Center

Disqualifiers: Under 18, Pregnant, Cognitive deficits, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess lung function in individuals recovering from COVID-19. It employs a special type of MRI, called hyperpolarized 129Xe MRI, which creates detailed images of the body's interior and provides a clear picture of air movement in the lungs. Individuals who have had COVID-19, are currently following up with their doctor, and have an oxygen level of at least 88% while resting may be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative lung imaging.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that hyperpolarized Xe129 MRI is safe for evaluating pulmonary function in COVID-19 survivors?

A previous study showed that hyperpolarized Xe129 MRI is a safe and effective method for examining lung function. This imaging technique is quick, taking less than 16 seconds, and involves no radiation exposure, making it non-invasive and safe for individuals, including those recovering from COVID-19. Research has not linked hyperpolarized Xe129 MRI to any major side effects or harmful events. As this study is in an early phase, researchers are primarily focused on ensuring its safety for humans, though more data will be needed for confirmation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hyperpolarized Xe129 MRI for COVID-19 survivors because it offers a unique way to visualize lung function at an unprecedented level of detail. Unlike traditional imaging methods like CT scans or standard MRIs, this technique uses hyperpolarized xenon gas, which patients inhale. This allows doctors to see how air is moving through the lungs in real-time, potentially identifying lingering issues post-COVID-19. It's a promising tool that could enhance our understanding of lung recovery and improve patient care.

What evidence suggests that hyperpolarized Xe129 MRI is effective for evaluating pulmonary function in COVID-19 survivors?

Research has shown that hyperpolarized Xe129 MRI effectively checks lung function after COVID-19. Studies indicate that this method can detect improvements in lung function and gas exchange in recovering patients. It offers a quick and safe way to examine lung health without radiation. In this trial, researchers will image COVID-19 survivors using hyperpolarized Xe129 MRI to identify lung changes that other methods might miss. Overall, it provides a clear view of lung recovery in COVID-19 survivors. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people who had COVID-19 and are in outpatient follow-up. They must be at least 10 days past the start of symptoms, without a fever, able to understand English or Spanish, and have an oxygen saturation of ≥88%. Pregnant individuals, those unable to fit into the MRI vest or hold their breath for about 15 seconds, under 18 years old, or with certain cognitive deficits cannot participate.

Inclusion Criteria

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 pregnant or lactating

Subject does not fit into 129Xe vest coil used for MRI

You are unable to hold your breath for 15-16 seconds.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo hyperpolarized 129Xe MRI to evaluate pulmonary structure and function

1 day

1 visit (in-person)

Follow-up

Participants are monitored for long-term pulmonary function impairment

6 months

Periodic assessments

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized Xe129

Trial Overview The study is testing hyperpolarized Xe129 MRI's ability to assess lung function in patients who've recovered from mild to severe COVID-19. It aims to provide insights on how well their lungs are working post-infection using this advanced imaging technique.

How Is the Trial Designed?

Group I: COVID-19 Survivors Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04659707

Hyperpolarized 129Xe MRI of Survivors of COVID-19 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11854573/

Hyperpolarized Xenon-129 MRI: Narrative Review of Clinical ... Post-COVID-19 patients showed improved lung function, gas exchange, and ... Hyperpolarized 129Xe MRI Abnormalities in Dyspneic Patients 3 Months after COVID-19 ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jmri.28940

Review of Hyperpolarized Pulmonary Functional 129 Xe ... Longitudinal improvements were observed in long-term follow-up of long-COVID patients but mean 129Xe gas-exchange, ventilation heterogeneity ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10036146/

Longitudinal Lung Function Assessment of Patients ... This study used a comprehensive 1H and 129Xe MRI protocol to assess pathophysiologic pulmonary changes in hospitalized patients with COVID-19 for up to 1 year ...

5. researchgate.net researchgate.net/publication/389063242_Hyperpolarized_Xenon-129_MRI_Narrative_Review_of_Clinical_Studies_Testing_and_Implementation_of_Advanced_Pulmonary_In_Vivo_Imaging_and_Its_Diagnostic_Applications

(PDF) Hyperpolarized Xenon-129 MRI: Narrative Review of ... ... Post-COVID-19 patients showed improved lung function, gas exchange ... Hyperpolarized 129Xe MRI Abnormalities in Dyspneic Patients 3 Months after ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9134268/

Lung Abnormalities Detected with Hyperpolarized 129Xe ... Summary. Hyperpolarized xenon 129 MRI and total lung diffusion capacity for carbon monoxide demonstrate significantly impaired gas transfer in nonhospitalized ...

7. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.220069

Lung Abnormalities Detected with Hyperpolarized 129 Xe ... Hyperpolarized xenon 129 MRI and total lung diffusion capacity for carbon monoxide demonstrate significantly impaired gas transfer in nonhospitalized ...

8. science.org science.org/doi/10.1126/sciadv.abc8180

Damaged lung gas exchange function of discharged ... Using 129 Xe MRI, we found that COVID-19 patients show a higher rate of ventilation defects (5.9% versus 3.7%), unchanged microstructure, and longer gas-blood ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2772516221000097

Evaluation of injuries caused by coronavirus disease 2019 ... We briefly reviewed the recent research on multi-nuclei MRI for evaluating injuries caused by COVID-19 and the clinical 1 H MRI techniques and their ...