129Xe MRI Cardiopulmonary

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBastiaan Driehuys

About this trial

The goal of this NIH-sponsored study is to characterize three biomarkers derived from 129Xe gas exchange MRI and to understand how they change in response to interventions.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Outpatients of either gender, age > 18

Willing and able to give informed consent and adhere to visit/protocol (Consent must be given before any study procedures are performed.)

Subject has no diagnosed pulmonary conditions

Subject has not smoked in the previous 5 years

Disqualifiers

MRI is contraindicated based on responses to MRI screening questionnaire

Subject is pregnant or lactating

Resting O2 saturation <90% with maximum supplemental O2 delivered by nasal canula

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyperpolarized Xe129

    Drug

    Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject TLC followed by a breath hold of up to 15 seconds.

  • Oxygen Administration

    Other intervention

    Oxygen administration

Treatment groups

125 Participants
are divided into 3 treatment groups
Group A: Transfusion and Phlebotomy PatientsActive comparator 1 intervention
Group B: Oxygen Administration PatientsActive comparator 2 interventions
Group C: Acute or Chronic Pulmonary Embolism PatientsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

The investigators will validate the Hb (hemoglobin) correction model in anemia patients pre/post transfusion and blood donors pre/post apheresis.

Time frame
Up to 5 days pre/post transfusion or apheresis
2

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

To test the effects of oxygen on 129Xe MRI/MRS in healthy subjects, those with ILD, those with dyspnea, and patients with chronic thromboembolic pulmonary hypertension (CTEPH).

Time frame
Baseline, 1 day
3

Change in RBC Oscillation Amplitude Post Therapy

Patients with chronic PE are treated surgically and those with acute PE are treated with anticoagulation therapy.

Time frame
Baseline, 3-6 months post-treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bastiaan Driehuys

Lead sponsor

Duke University

Sponsor institution

National Institutes of Health (NIH)

Collaborator