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Hyperpolarized 129Xe MRI for Pulmonary Arterial Hypertension (PH SOLAR Trial)

Phase 2

Recruiting

Led By Sudarshan Rajagopal, MD, PhD

Research Sponsored by Bastiaan Driehuys

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis of IPF with precapillary PH

Clinical diagnosis of IPF in the absence of precapillary PH

Must not have

Moderate to severe heart disease (LVEF < 45% or severe LV Hypertrophy)

Sarcoidosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a new magnetic resonance imaging (MRI) technique can be used to identify which patients with a certain kind of lung disease will respond to treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves MRI scanning with hyperpolarized Xenon gas rather than medication, typical drug side effects aren't expected. However, there may be risks associated with undergoing an MRI scan such as discomfort from lying still.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I have been diagnosed with PAH and do not have severe lung or heart disease, or conditions like sarcoidosis.

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I am 18 years old or older.

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I have been diagnosed with COPD and do not have precapillary pulmonary hypertension.

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I have been diagnosed with COPD and pulmonary hypertension.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been diagnosed with sarcoidosis.

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My cancer is currently active.

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I have sickle cell anemia.

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My liver condition is severe.

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I am unable to give consent for medical procedures.

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I can undergo an MRI scan without issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

a pathology-based 129Xe MRI noninvasive signature of pulmonary vascular remodeling that could be validated in a larger cohort of Group 3 PH patients

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: PAH:Experimental Treatment1 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-noPHExperimental Treatment1 Intervention

Clinical diagnosis of IPF in the absence of precapillary PH

Group III: IPF-PHExperimental Treatment1 Intervention

Clinical diagnosis of IPF with precapillary PH

Group IV: COPD-noPHExperimental Treatment1 Intervention

Clinical diagnosis of COPD in the absence of precapillary PH.

Group V: COPD-PHExperimental Treatment1 Intervention

Clinical diagnosis of COPD with precapillary PH

0 / 13Eligibility criteria met