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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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