New MRI technique reveals hidden Lung-Heart problems
NCT ID NCT06038630
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study uses a special type of MRI (called 129Xe gas exchange MRI) to take detailed pictures of how the lungs and heart work together. Researchers want to understand how these images change after treatments like blood transfusions or oxygen therapy. The study involves 125 adults with lung disease, blood disorders, or shortness of breath, as well as healthy volunteers.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 125 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2024
- Expected to finish
-
Jun 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for Healthy Volunteers: (Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial) 1. Outpatients of either gender, age \> 18 2. Willing and able to give informed consent and adhere to visit/protocol (Consent must be given before any study procedures are performed.) 3. Subject has no diagnosed pulmonary conditions 4. Subject has not smoked in the previous 5 years 5. Smoking history, if any, is less than or equal to 5 pack-years 6. No history of using other inhaled products more than 1/week for \> 1 year Inclusion Criteria for Transfusion and Phlebotomy Patients: 1. In-patient or outpatients of either sex, age \> 18 2. Willing and able to give informed consent and adhere to visit/protocol And one of the following: 1. Patients who are scheduled to receive a red cell transfusion for anemia. 2. Patients who are scheduled to undergo therapeutic phlebotomy to treat erythrocytosis or polycythemia 3. Healthy volunteers undergoing voluntary whole blood donation (healthy volunteer inclusion criteria noted above) Inclusion Criteria for Oxygen Administration Patients: 1. In-patient or outpatients of either sex, age \> 18 2. Willing and able to give informed consent and adhere to visit/protocol And one of the following categories (ILD, Dyspnea, CTEPH, or Healthy): 1. Interstitial Lung Disease or Dyspnea * Physician diagnosis of Interstitial Lung Disease by a pulmonologist using established criteria or physician referral of patient with dyspnea OR 2. Chronic Thromboembolic Pulmonary Hypertension (CTEPH) * Patients with a diagnosis of CTEPH, defined as mean PA pressure \>20 mmHg with a pulmonary vascular resistance \>2 WU and pulmonary capillary wedge pressure ≤15 mmHg at right heart catheterization with evidence of chronic thromboembolic disease on clinical imaging after 3 months of anticoagulation * Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to re-turn 3-6 months after for optional follow-up scans OR 3. Healthy Volunteer (criteria noted above) Inclusion Criteria for Acute or Chronic Pulmonary Embolism Patients: 1. In-patient or outpatients of either sex, age \> 18 2. Willing and able to give informed consent and adhere to visit/protocol And one of the following categories (Acute or Chronic) 1. Acute Pulmonary Embolism * Patients presenting with acute PE 24-48hrs post-admission * Willing to return after 3-6 months of anti-coagulation therapy OR 2. Chronic Thromboembolic Pulmonary Hypertension (CTEPH) * Patients with a diagnosis of CTEPH, defined as mean PA pressure \>20 mmHg with a pulmonary vascular resistance \>2 WU and pulmonary capillary wedge pressure ≤15 mmHg at right heart catheterization with evidence of chronic thromboembolic disease on clinical imaging after 3 months of anticoagulation * Scheduled for pulmonary thromboendoarterectomy (PTE) surgery and willing to re-turn 3-6 months after for optional follow-up scans Exclusion Criteria for All subjects: Subjects presenting with any of the following will not be included in the trial: 1. MRI is contraindicated based on responses to MRI screening questionnaire 2. Subject is pregnant or lactating 3. Resting O2 saturation \<90% with maximum supplemental O2 delivered by nasal canula 4. Respiratory illness of a bacterial or viral etiology within 30 days of MRI 5. Subject has history of any known ventricular cardiac arrhythmia 6. Subject has history of cardiac arrest within the last year 7. Subject does not fit into 129Xe vest coil used for MRI 8. Subject cannot hold his/her breath for 10 seconds 9. Subject deemed unlikely to be able to comply with instructions during imaging 10. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute pulmonary embolism are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Duke University Medical Center
RECRUITINGDurham, North Carolina, 27710, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can scheduled malaria drugs shield infants from severe illness?
- Can rehabilitation boost confidence in fibrotic lung disease?
- Can a simple preventive drug cut malaria and anemia in infants?
- Inhaled therapy aims to slow the march of progressive pulmonary fibrosis
- Can a new Five-Category system predict which pulmonary embolism patients will crash?
- Can a thousand patient records unlock better care for a rare lung disease?