Hyperpolarized 129Xe MRI for Pulmonary Arterial Hypertension

(PH SOLAR Trial)

Overseen By Claudia Salazar

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bastiaan Driehuys

Disqualifiers: Heart disease, Sarcoidosis, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6-8 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to detect changes in the lungs of individuals with certain types of pulmonary hypertension (high blood pressure in the lungs) using a special MRI technique called Hyperpolarized 129Xe MRI. The researchers aim to identify patterns that might indicate who could benefit from specific treatments for pulmonary arterial hypertension. The trial seeks participants with chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF), who may or may not have pulmonary hypertension and are awaiting a lung transplant. Participants must be able to undergo MRI scans and provide informed consent. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in pulmonary care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that hyperpolarized 129Xe MRI is safe for pulmonary arterial hypertension patients?

Research has shown that hyperpolarized 129Xe MRI is generally safe for humans and is a reliable method for assessing lung function. This imaging tool examines lung ventilation (air movement) and gas exchange (oxygen transfer from air to blood) without causing harm.

Studies reviewed have reported no major safety issues, indicating that patients tolerate it well. Although the studies did not mention any negative effects, the regular use of hyperpolarized 129Xe MRI in research supports its safety.

As this is a Phase 2 trial, earlier studies have already demonstrated some safety. While more information is being gathered, the risk of major side effects is likely low based on current knowledge. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using hyperpolarized 129Xe MRI for pulmonary arterial hypertension (PAH) because it offers a new way to visualize lung function in real-time, unlike current treatments that focus on managing symptoms or targeting blood vessel constriction. This imaging technique uses hyperpolarized xenon gas, allowing doctors to see how gas moves through the lungs and how blood flows, providing a detailed picture of lung health. The potential to detect and understand lung issues earlier and more accurately could lead to better, more personalized treatment plans, setting it apart from existing therapies that mainly aim to alleviate symptoms without such detailed insights.

What evidence suggests that hyperpolarized 129Xe MRI is effective for identifying pulmonary vascular remodeling in Group 3 PH patients?

Research has shown that hyperpolarized 129Xe MRI holds promise for detecting pulmonary hypertension (PH). This technique uses a special gas to create clear lung images, aiding doctors in assessing lung function. It has effectively identified changes in lung structure and function related to PH. In this trial, participants will be grouped based on specific lung conditions, such as COPD or IPF, with or without precapillary PH, and PAH. This imaging method can help identify patients who might benefit from specific PH treatments. Although researchers continue to study the technology, early findings suggest it could become an important tool in managing lung conditions like pulmonary arterial hypertension (PAH). ^{3 4 6 7 8}

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 over 18 with certain lung diseases like IPF or COPD, with or without high blood pressure in the lungs (PH). Participants must not have severe heart disease, active cancer, liver disease, sarcoidosis, sickle cell anemia, and should be able to undergo MRI scans. Pregnant women and prisoners are excluded.

Inclusion Criteria

Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed)

I have been diagnosed with IPF and high blood pressure in the lungs.

I have been diagnosed with IPF without high blood pressure in the lungs.

Exclusion Criteria

Prisoners and pregnant women will not be approached for the study

My heart function is reduced (LVEF < 45%) or I have severe thickening of my heart walls.

I have been diagnosed with sarcoidosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline 129Xe MRI to establish initial pulmonary vascular remodeling signature

1 day

1 visit (in-person)

Treatment

Participants receive PAH-specific therapies and undergo 129Xe MRI to monitor changes in pulmonary vascular remodeling

6-8 weeks

2-3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized 129Xe

Trial Overview The study tests a noninvasive imaging technique using hyperpolarized Xenon gas (129Xe) during MRI to detect changes in the lungs' blood vessels of patients with Group 3 Pulmonary Hypertension. It aims to find a signature that predicts response to specific therapies.

How Is the Trial Designed?

Group I: PAH: Experimental Treatment 1 Intervention

Clinical diagnosis of PAH (Group 1 PH) in the absence of severe chronic lung disease, left heart disease, chronic thromboembolism, sarcoidosis, sickle cell disease or other causes of non-Group 1 PH.

Group II: IPF-noPH Experimental Treatment 1 Intervention

Clinical diagnosis of IPF in the absence of precapillary PH

Group III: IPF-PH Experimental Treatment 1 Intervention

Clinical diagnosis of IPF with precapillary PH

Group IV: COPD-noPH Experimental Treatment 1 Intervention

Clinical diagnosis of COPD in the absence of precapillary PH.

Group V: COPD-PH Experimental Treatment 1 Intervention

Clinical diagnosis of COPD with precapillary PH

Who Is Running the Clinical Trial?

Bastiaan Driehuys

Lead Sponsor

Trials

15

Recruited

1,100+

Published Research Related to This Trial

Hyperpolarized 129 Xenon-MRI (HP 129 Xe MRI) is a new imaging technique that can assess both how well air moves in and out of the lungs (ventilation) and how effectively gases are transferred in the lungs.

While most studies have focused on non-cancer lung diseases, HP 129 Xe MRI shows great potential for improving the management and understanding of lung cancer by evaluating these key lung functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI. Song, EJ., Kelsey, CR., Driehuys, B., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Hyperpolarized 129Xe MRI is a new imaging technique that allows for detailed lung imaging and can also detect 129Xe in the brain, providing insights into brain parenchyma and blood vessels.

The study outlines specific protocols for using 129Xe MRI in both rodents and humans, highlighting its potential for advanced medical imaging applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain Imaging Using Hyperpolarized 129Xe Magnetic Resonance Imaging. Chahal, S., Prete, BRJ., Wade, A., et al.[2019]

The study introduces a new method for delivering hyperpolarized (129)Xe gas directly into the arterial blood of live rats using an extracorporeal circuit, allowing for continuous infusion and improved imaging capabilities.

This technique enables high-resolution, 3D MRI of lung ventilation and perfusion, facilitating detailed studies of the ventilation-perfusion ratio and potentially expanding the use of (129)Xe for functional imaging in other body areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo MR imaging of pulmonary perfusion and gas exchange in rats via continuous extracorporeal infusion of hyperpolarized 129Xe. Cleveland, ZI., Möller, HE., Hedlund, LW., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeatability of regional pulmonary functional metrics of Hyperpolarized 129 Xe dissolved-phase MRI. Hahn, AD., Kammerman, J., Evans, M., et al.[2020]

Hyperpolarized 129Xe MRI (HypX-MRI) shows great promise as a new diagnostic tool, enhancing the detectability of lung structures and potentially allowing for better imaging of lipid-rich tissues, which has been challenging with traditional methods.

This technique could help identify issues like ventilation-perfusion mismatch in pulmonary diseases and may also be used for functional MRI studies of the brain, opening new avenues for understanding lung function and brain perfusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of hyperpolarized noble gas MRI. Albert, MS., Balamore, D.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9108963/

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.

2. pubs.rsna.org pubs.rsna.org/doi/10.1148/ryct.240562

Hyperpolarized 129Xe MRI and Spectroscopy: Quantitative ... Hyperpolarized xenon 129 (129Xe) MRI uses inhaled 129Xe gas to visualize pulmonary function and microstructure.

3. tandfonline.com tandfonline.com/doi/full/10.1080/17476348.2025.2529543

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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S266644102400030X

A standardized MRI phantom for dissolved phase 129Xe MRI This work introduces a new phantom concept that reproduces clinical MRI. Suitable phantom materials are identified and characterized via hp 129 Xe NMR and MRI.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6318005/

Hyperpolarized 129Xe Gas Transfer MRI: The Transition ... Hyperpolarized 129Xe MRI depicting 3D ventilation, interstitial barrier uptake and transfer to red blood cells (RBCs) has emerged as a powerful new means of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10294784/

Hyperpolarized Xenon-129: A New Tool to Assess Pulmonary ... A high-resolution chest CT provides excellent morphologic data on the correlates of inflammation and fibrosis but limited physiologic data.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03002389

Hyperpolarized Xenon-129 MRI: a New Multi-dimensional ... Hyper polarized xenon-129 MRI (HXe MRI) is a unique imaging test which can detect how air is flowing in and out of lungs and how oxygen can move from ...

8. mdpi.com mdpi.com/2075-4418/15/4/474

Hyperpolarized Xenon-129 MRI: Narrative Review of ... Hyperpolarized xenon-129 MRI (129XeMRI) has emerged as a powerful tool in the identification, evaluation, and assessment of disease endotyping and in ...