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129Xe MRI for Lung Disease

Phase 2

Recruiting

Led By Joseph Mammarappallil, MD

Research Sponsored by Bastiaan Driehuys

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Respiratory illness of a bacterial or viral etiology within 30 days of MRI

Subject has history of cardiac arrest within the last year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3-6 months post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how 3 biomarkers change when people respond to treatments. It's funded by the US National Institutes of Health.

Who is the study for?

This trial is for adults over 18 with interstitial lung disease, thromboembolic pulmonary hypertension, or who are healthy volunteers. Participants must be able to give consent and follow the study plan. Smokers or those with recent respiratory illness, certain heart conditions, low oxygen levels, MRI contraindications, inability to hold breath for 10 seconds, pregnancy or lactation are excluded.

What is being tested?

The study tests how three biomarkers from a special type of MRI using hyperpolarized Xenon gas (129Xe) change in response to interventions like oxygen administration. It aims to improve understanding of various lung diseases and their treatment.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort from wearing the MRI vest coil and holding one's breath during imaging. Oxygen administration can sometimes cause dryness of nasal passages or mild headache.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had a lung infection in the last 30 days.

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I had a cardiac arrest in the last year.

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I cannot hold my breath for 10 seconds.

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I have a history of irregular heartbeats from the lower chambers of my heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3-6 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3-6 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3-6 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in RBC (red blood cell) Chemical Shift After Oxygen Administration

Change in RBC Oscillation Amplitude Post Therapy

Change in RBC to Membrane Ratio Pre and Post Transfusion or Apheresis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Transfusion and Phlebotomy PatientsActive Control1 Intervention

Individuals receiving treatment for their blood hemoglobin levels or are a healthy volunteer who is planning to donate blood.

Group II: Oxygen Administration PatientsActive Control2 Interventions

Individuals diagnosed with a chronic blood clot in their lungs and are planning on having surgery to remove it (CTEPH), or have an interstitial lung disease (ILD), or have dyspnea, or are a healthy volunteer.

Group III: Acute or Chronic Pulmonary Embolism PatientsActive Control1 Intervention

Individuals recently diagnosed with a blood clot in their lungs.

0 / 4Eligibility criteria met