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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 yrs

Awards & highlights

PH SOLAR Trial 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.Check my eligibility

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.See study design

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.

PH SOLAR Trial 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.

PH SOLAR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 yrs

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 yrs

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 yrs for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

PH SOLAR 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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bastiaan DriehuysLead Sponsor

14 Previous Clinical Trials

1,051 Total Patients Enrolled

4 Trials studying Pulmonary Arterial Hypertension

94 Patients Enrolled for Pulmonary Arterial Hypertension

Sudarshan Rajagopal, MD, PhDPrincipal InvestigatorDuke University

4 Previous Clinical Trials

100 Total Patients Enrolled

2 Trials studying Pulmonary Arterial Hypertension

74 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

Hyperpolarized 129Xe Clinical Trial Eligibility Overview. Trial Name: NCT04778046 — Phase 2

Pulmonary Arterial Hypertension Research Study Groups: COPD-PH, IPF-noPH, COPD-noPH, IPF-PH, PAH:

Pulmonary Arterial Hypertension Clinical Trial 2023: Hyperpolarized 129Xe Highlights & Side Effects. Trial Name: NCT04778046 — Phase 2

Hyperpolarized 129Xe 2023 Treatment Timeline for Medical Study. Trial Name: NCT04778046 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is utilizing Hyperpolarized 129Xe a secure practice for humans?

"Given the Phase 2 clinical trial status, our team at Power assigned a score of two to hyperpolarized 129Xe's safety. Although there is evidence for its security, efficacy has yet to be verified."

Answered by AI

How many volunteers are engaged in this experiment?

"Affirmative. According to data on clinicaltrials.gov, this medical endeavour is still recruiting volunteers; the trial was first initiated in December 15th 2022 and was recently updated on October 5th 2022. 30 patients are needed for 1 centre involved with the study."

Answered by AI

Are there currently vacancies within this clinical experiment?

"Clinicaltrials.gov indicates that this clinical trial is open to enrollment, with the original posting occurring on December 15th 2022 and an update issued on October 5th 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pulmonary Hypertension SOLAR

Bastiaan Driehuys 2023. "Pulmonary Hypertension SOLAR". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04778046.

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