129 Xenon MRI for Pulmonary Arterial Hypertension

(Xenon PAH Bio Trial)

Overseen By David Ptashnik, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bastiaan Driehuys

Disqualifiers: PH other than IPAH or PAH-CTD, 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 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The overall study objectives outlined in this study are to derive 129Xe MRI pulmonary vascular biomarker signatures that differentiate common subtypes of PAH and to determine the ability of 129Xe MRI to longitudinally monitor disease progression and response to therapy in PAH, with the aid of additional assessments, such as labs, echocardiography, and six-minute walk distance (6MWD).

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 trial coordinators or your doctor.

Is 129 Xenon MRI safe for humans?

Research on hyperpolarized 129 Xenon MRI (HP 129 Xe MRI) suggests it is generally safe for use in humans, including children, as it has been used in studies for lung and brain imaging. However, its safety and tolerability, especially in children, have not been rigorously assessed, indicating more research is needed to fully understand its safety profile. ^{1 2 3 4 5}

How does the 129 Xenon MRI treatment differ from other treatments for pulmonary arterial hypertension?

The 129 Xenon MRI treatment is unique because it uses a special type of imaging to assess lung function by evaluating both ventilation and gas transfer, which is not typically done with standard treatments for pulmonary arterial hypertension. This imaging technique can help in diagnosing and monitoring the condition by providing detailed insights into lung physiology. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment 129 Xenon MRI for Pulmonary Arterial Hypertension?

Research shows that Hyperpolarized 129 Xenon MRI can effectively assess lung function by evaluating ventilation and gas transfer, which are crucial for diagnosing and monitoring pulmonary vascular diseases. This imaging technique has demonstrated the ability to detect abnormalities in gas exchange in the lungs, suggesting its potential usefulness in managing conditions like pulmonary arterial hypertension. ^{1 2 3 6 7}

Who Is on the Research Team?

Fawaz Alenezi, MD

Principal Investigator

Duke Univeristy

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with Pulmonary Arterial Hypertension (PAH), either idiopathic or associated with connective tissue disease. Participants must have specific heart and lung pressure measurements, be in WHO functional class 2 or 3, and not have other causes for PAH. Those unable to undergo a 129Xe MRI scan or with different types of pulmonary hypertension are excluded.

Inclusion Criteria

For Arm 1, if you have high blood pressure in your lung arteries (more than 20 mmHg), you will not be able to participate.

I have been diagnosed with a connective tissue disease.

In Arm 2, if you have pulmonary capillary wedge pressure greater than 15 mmHg, you cannot participate in the study.

Exclusion Criteria

You have any medical conditions that make it impossible to do 129Xe MRI scans.

My pulmonary hypertension is not caused by idiopathic PAH or connective tissue disease.

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/MRS and standard of care assessments including labs, echocardiography, and six-minute walk distance (6MWD)

1 visit

1 visit (in-person)

Longitudinal Monitoring

Participants undergo 129Xe MRI/MRS and standard of care assessments at 3, 6, and 12 months to monitor disease progression and response to therapy

12 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main observation period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 129 Xenon MRI

Trial Overview The study tests the use of a special type of MRI scan using hyperpolarized Xenon gas (129Xe) as a way to identify different subtypes of PAH and monitor changes over time in response to treatment. It will be used alongside other assessments like blood tests, echocardiograms, and walking distance measures.

How Is the Trial Designed?

Group I: Pulmonary Arterial Hypertension Associated with Connective Tissue Disease Experimental Treatment 1 Intervention

Arm 2... patients with CTD-PAH

Group II: Idiopathic Pulmonary Arterial Hypertension Experimental Treatment 1 Intervention

Arm 1... patients with IPAH

Who Is Running the Clinical Trial?

Bastiaan Driehuys

Lead Sponsor

Trials

15

Recruited

1,100+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

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 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 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 (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 (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]

Hyperpolarized 129Xe gas is safe and well-tolerated as an inhaled contrast agent for MRI in children, with no serious adverse events reported during the study involving 28 participants aged 6 to 16 years.

While some children experienced mild and temporary changes in oxygen saturation and heart rate after inhalation, these effects were consistent with expected physiological responses and resolved quickly, indicating that 129Xe MRI is feasible for assessing lung function in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, tolerability and safety of pediatric hyperpolarized 129Xe magnetic resonance imaging in healthy volunteers and children with cystic fibrosis. Walkup, LL., Thomen, RP., Akinyi, TG., et al.[2022]

Hyperpolarized noble gas MRI using helium-3 or xenon-129 enhances MRI signal, making it a promising method for imaging lung function and ventilation.

While there are safety considerations and challenges in clinical application, this technology holds potential for better understanding lung microstructure and function in various pulmonary diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary hyperpolarized noble gas MRI: recent advances and perspectives in clinical application. Liu, Z., Araki, T., Okajima, Y., et al.[2017]

Citations

1. Australia pubmed.ncbi.nlm.nih.gov

Functional airway obstruction observed with hyperpolarized 129 Xenon-MRI. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Brain Imaging Using Hyperpolarized 129Xe Magnetic Resonance Imaging. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Repeatability of regional pulmonary functional metrics of Hyperpolarized 129 Xe dissolved-phase MRI. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Abnormalities in hyperpolarized (129)Xe magnetic resonance imaging and spectroscopy in two patients with pulmonary vascular disease. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Development of hyperpolarized noble gas MRI. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Feasibility, tolerability and safety of pediatric hyperpolarized 129Xe magnetic resonance imaging in healthy volunteers and children with cystic fibrosis. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Pulmonary hyperpolarized noble gas MRI: recent advances and perspectives in clinical application. [2017]