Xenon MRI for Pulmonary Arterial Hypertension
(Jupiter PH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a special type of MRI using 129Xe gas (known as 129Xe Hyperpolarized) can help understand and track pulmonary arterial hypertension (PAH), a condition where high blood pressure affects the lungs and heart. Researchers aim to see how changes inside the lungs relate to the disease and its treatment. This study targets individuals waiting for a lung transplant or those with PAH symptoms who have recently started treatment. Participants should have a diagnosis of specific types of high blood pressure affecting the lungs and be able to undergo MRI scans. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people, offering participants a chance to contribute to important advancements in PAH management.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are in Cohort 2, you must be either treatment naïve or have started treatment within the last 3 months.
What prior data suggests that 129Xe Hyperpolarized MRI/MRS is safe for pulmonary arterial hypertension patients?
Research has shown that hyperpolarized 129Xe MRI is safe for both healthy individuals and patients with conditions like cystic fibrosis and chronic obstructive pulmonary disease (COPD). This suggests the procedure is generally well-tolerated. In these studies, no major side effects were reported, indicating the safety of this imaging technique. Although the current trial remains in its early stages, the absence of significant adverse events in previous research is encouraging for potential participants.12345
Why are researchers excited about this trial?
Researchers are excited about using 129Xe Hyperpolarized MRI for pulmonary arterial hypertension because it offers a unique, non-invasive way to visualize lung function in real-time. Unlike current treatments that focus on managing symptoms or slowing disease progression, this technique allows for detailed imaging of gas exchange and lung ventilation without the need for radiation. This could lead to earlier and more accurate diagnosis and monitoring, potentially improving patient outcomes and guiding personalized treatment strategies.
What evidence suggests that 129Xe Hyperpolarized MRI/MRS is effective for pulmonary arterial hypertension?
Research has shown that hyperpolarized 129Xe MRI holds promise for diagnosing and understanding pulmonary arterial hypertension (PAH). This trial will use 129Xe MRI to produce clear images of lung gas exchange, crucial for assessing PAH. It has been safely used in both healthy individuals and those with lung issues, indicating its potential to effectively monitor PAH progression. This imaging method aids doctors in distinguishing between various heart and lung conditions, offering a clearer view of the disease. Overall, 129Xe MRI offers a noninvasive method to track changes in lung function related to PAH.13456
Who Is on the Research Team?
Sudarshan Rajagopal, MD, PhD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 with Pulmonary Hypertension (PH), specifically those who are newly diagnosed or have started treatment within the last three months. Participants must be able to consent and follow the study schedule, and women of childbearing age need a negative pregnancy test before MRI scans. Those awaiting lung transplants can join too, but not if they have severe liver disease, heart issues, active cancer, sickle cell anemia or conditions preventing MRI use.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo 129Xe MRI scans and standard-of-care assessments including labs, echocardiography, and six-minute walk distance
Follow-up
Participants are monitored for safety and effectiveness after treatment, with 6-month follow-up appointments
What Are the Treatments Tested in This Trial?
Interventions
- 129Xe Hyperpolarized
129Xe Hyperpolarized is already approved in United States for the following indications:
- Pulmonary hypertension (investigational)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bastiaan Driehuys
Lead Sponsor