RecruitingPhase 2

129Xe MRI Cardiopulmonary

United States125 participantsStarted 2024-01-12

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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
✓. Smoking history, if any, is less than or equal to 5 pack-years
✓. No history of using other inhaled products more than 1/week for \> 1 year
✓. In-patient or outpatients of either sex, age \> 18
✓. Willing and able to give informed consent and adhere to visit/protocol

Exclusion criteria

✕. 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
✕. Subject has history of any known ventricular cardiac arrhythmia
✕. Subject has history of cardiac arrest within the last year
✕. Subject does not fit into 129Xe vest coil used for MRI
✕. Subject cannot hold his/her breath for 10 seconds

What they're measuring

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

Timeframe: Up to 5 days pre/post transfusion or apheresis

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

Timeframe: Baseline, 1 day

Change in RBC Oscillation Amplitude Post Therapy

Timeframe: Baseline, 3-6 months post-treatment

Trial details

NCT IDNCT06038630

SponsorBastiaan Driehuys

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-30

Contact for this trial

Bastiaan Driehuys, PhD

919-684-7786 bastiaan.driehuys@duke.edu

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