129Xe MRI Cardiopulmonary

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Bastiaan Driehuys
Study ID
NCT06038630
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Pulmonary Embolism
  • Anemia
  • Chronic Thromboembolic Pulmonary Hypertension
  • Dyspnea
  • Interstitial Lung Disease
  • Polycythemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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
    Oxygen administration

Study Details

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.

Key Dates

Start date
Jan 12, 2024
Status verified
Feb 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
125 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Transfusion and Phlebotomy Patients
    Individuals receiving treatment for their blood hemoglobin levels or are a healthy volunteer who is planning to donate blood.
  • Active Comparator: Oxygen Administration Patients
    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.
  • Active Comparator: Acute or Chronic Pulmonary Embolism Patients
    Individuals recently diagnosed with a blood clot in their lungs.

Primary Outcome Measure

Change in RBC to Membrane Ratio Pre and Post Transfusion or Apheresis [ Time Frame: Up to 5 days pre/post transfusion or apheresis ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Cody Blanton
[email protected]
919-668-7575
Jennifer Korzekwinski
[email protected]
919-681-7362
Joseph Mammarappallil, MD (PRINCIPAL_INVESTIGATOR)
Bastiaan Driehuys, PhD (SUB_INVESTIGATOR)

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By research site
Duke University Medical Center· Durham, NC

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