60 Participants Needed

Xenon MRI for Pulmonary Arterial Hypertension

(Jupiter PH Trial)

SW
SA
DP
CS
Overseen ByClaudia Salazar
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Bastiaan Driehuys
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

SR

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

Willing and giving informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed)
Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed)
Women of childbearing potential must have a negative urine pregnancy test before MRI
See 4 more

Exclusion Criteria

Prisoners and pregnant women will not be approached for the study
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
I have sickle cell anemia.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 129Xe MRI scans and standard-of-care assessments including labs, echocardiography, and six-minute walk distance

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with 6-month follow-up appointments

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • 129Xe Hyperpolarized
Trial Overview The trial is testing how a type of imaging called Xenon 129 Magnetic Resonance Imaging (MRI) can show changes in lung function and blood flow in patients with different types of Pulmonary Hypertension. It aims to understand how these images change with disease progression or after starting treatment.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: following pulmonary arterial hypertension subjectsExperimental Treatment1 Intervention
Group II: end-stage pulmonary hypertension .Experimental Treatment1 Intervention

129Xe Hyperpolarized is already approved in United States for the following indications:

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Approved in United States as Hyperpolarized 129Xe for:

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Who Is Running the Clinical Trial?

Bastiaan Driehuys

Lead Sponsor

Trials
15
Recruited
1,100+

Published Research Related to This Trial

This study is the first to use hyperpolarized 129Xe MRI to non-invasively assess pulmonary hypertension in a monocrotaline rat model, showing reduced gas exchange early in the disease and changes in tissue uptake later on.
The imaging results correlated well with histological findings, indicating that 129Xe MRI could be a valuable tool for monitoring disease progression and treatment response in pulmonary hypertension without the need for invasive procedures.
Quantitative 129Xe MRI detects early impairment of gas-exchange in a rat model of pulmonary hypertension.Virgincar, RS., Nouls, JC., Wang, Z., et al.[2021]
Hyperpolarized (HP) (129)Xe MRI effectively identified significant pulmonary vascular disease (PVD) in two patients who had normal ventilation but decreased gas transfer, despite inconclusive results from other imaging methods.
The technique shows promise for diagnosing PVD and monitoring treatment responses, but further research is needed to establish its sensitivity and specificity.
Abnormalities in hyperpolarized (129)Xe magnetic resonance imaging and spectroscopy in two patients with pulmonary vascular disease.Dahhan, T., Kaushik, SS., He, M., et al.[2023]
The study involving 13 healthy volunteers demonstrated that MRI measurements of gas exchange using hyperpolarized 129 Xenon show good repeatability, particularly for the RBC:Barrier ratio, which had a high intraclass correlation coefficient of 0.92.
The RBC:Barrier ratio was strongly correlated with intervisit changes in DLCO, indicating its potential as a reliable imaging biomarker for assessing pulmonary function, independent of lung inflation volume.
Repeatability of regional pulmonary functional metrics of Hyperpolarized 129 Xe dissolved-phase MRI.Hahn, AD., Kammerman, J., Evans, M., et al.[2020]

Citations

Noninvasive diagnosis of pulmonary hypertension with ...This study demonstrates the potential to develop 129 Xe MRI/MRS into a modality with good accuracy in detecting pre- and post-capillary PH.
The emerging role of hyperpolarized 129 Xe MRI in ...129 Xe MRI/MRS is an emerging functional lung imaging technology that provides spatial and quantitative metrics of pulmonary ventilation, interstitial membrane ...
Hyperpolarized 129 Xe MRI and SpectroscopyThis review aims to summarize established and emerging quantitative measurements derived from 129Xe MRI and MR spectroscopy (MRS) and illustrate ...
129Xe Imaging for Pulmonary Arterial HypertensionResearch shows that hyperpolarized 129Xe MRI has been safely used in both healthy volunteers and patients with conditions like cystic fibrosis and chronic ...
A standardized MRI phantom for dissolved phase 129Xe MRIHp129Xe MRI and MRS can be utilised to differentiate between cardiopulmonary function impairment in COPD, IPF, left heart failure (LHF) and pulmonary arterial ...
Study Details | NCT06104228 | 129 Xenon MRI as a ...The overall study objectives outlined in this study are to derive 129Xe MRI pulmonary vascular biomarker signatures that differentiate common subtypes of PAH ...
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