Interstitial Lung DiseasePhase 2PH SOLARNCT04778046
Pulmonary Hypertension SOLAR
A Phase 2 study testing Hyperpolarized 129Xe in people with Interstitial Lung Disease and COPD, run by Bastiaan Driehuys at 1 site in United States.
Trial summary
The main goal of this study is to develop a noninvasive signature for pulmonary vascular remodeling in Group 3 PH patients, using hyperpolarized 129Xe magnetic resonance imaging (129Xe MRI). Such a signature may identify Group 3 PH responders to PAH-specific therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, COPD, Pulmonary Arterial Hypertension
- What is being tested?
- Hyperpolarized 129Xe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2023to 31 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years' old
- Be on the lung transplant waiting list at Duke University Medical Center.
- PH as defined by RHC - mPAP > 20 mmHg, PVR > 3 WU, PCWP < 15 mmHg
- Groups defined as:
- PAH: 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.
- COPD-noPH: Clinical diagnosis of COPD in the absence of precapillary PH.
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- COPD-PH: Clinical diagnosis of COPD with precapillary PH.
- IPF-noPH: Clinical diagnosis of IPF in the absence of precapillary PH.
- IPF-PH: Clinical diagnosis of IPF with precapillary PH.
- Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
Who cannot join
- Moderate to severe heart disease (LVEF < 45% or severe LV Hypertrophy).
- Sarcoidosis.
- Active cancer.
- Sickle cell anemia.
- Liver disease (Childs-Pugh class C).
- Prisoners and pregnant women will not be approached for the study.
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- Inability to obtain consent.
- Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine).
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
David Ptashnik, MS, 919-668-2642, david.ptashnik@duke.edu
Sudarshan Rajagopal, MD, PhD
About this study
Official title: Defining a Noninvasive Signature for Pulmonary Vascular Remodeling in Group 3 PH
The main goal of this study is to develop a noninvasive signature for pulmonary vascular remodeling in Group 3 PH patients, using hyperpolarized 129Xe magnetic resonance imaging (129Xe MRI). Such a signature may identify Group 3 PH responders to PAH-specific therapies. PAH's unique 129Xe MRI signature has been shown in previous studies. Past studies have lacked a pathologic "ground truth" correlate of these signatures, which could be provided by comparing them with the pathology of lung explant tissue from patients who have undergone a lung transplant. This signature could be validated in a cohort of patients with Group 3 PH in future studies.
Read the detailed description
The objective of this study is to identify a 129Xe MRI signature associated with PAH-like pulmonary vascular remodeling, consisting of plexiform arteriopathy, smooth muscle cell proliferation, and vascular fibrosis, in IPF and COPD that could be used to identify potential responders vs non-responders to PAH-specific therapies. The central hypothesis is that similar mechanisms and pathways underlie pulmonary vascular remodeling in IPF-PH, COPD-PH, and PAH. However, only a subset of Group 3 PH patients display remodeling consistent with PAH, resulting in responder vs. non-responder phenotypes when treated with PAH-specific therapies. In preliminary studies of subjects treated with Tyvaso, The study team has observed distinct 129Xe MRI signatures at baseline and with therapy depending on patients' underlying lung function. Consistent with this, recent studies using single-cell RNA sequencing (scRNAseq) of the pulmonary vasculature in IPF have demonstrated changes consistent with vascular remodeling.
- Being tested
- Hyperpolarized 129Xe
- Keywords
- Lung Transplant, Group 3 PH
- Medical subject headings
- Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 129XeDrug
Also called Xe MRI
Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),
| Study group | Role | What they receive |
|---|---|---|
| PAH: | Experimental | 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. Receives: Drug: Hyperpolarized 129Xe |
| COPD-noPH | Experimental | Clinical diagnosis of COPD in the absence of precapillary PH. Receives: Drug: Hyperpolarized 129Xe |
| COPD-PH | Experimental | Clinical diagnosis of COPD with precapillary PH Receives: Drug: Hyperpolarized 129Xe |
| IPF-noPH | Experimental | Clinical diagnosis of IPF in the absence of precapillary PH Receives: Drug: Hyperpolarized 129Xe |
| IPF-PH | Experimental | Clinical diagnosis of IPF with precapillary PH Receives: Drug: Hyperpolarized 129Xe |
What is being measured
The primary outcome is the main question the study is designed to answer.
a pathology-based 129Xe MRI noninvasive signature of pulmonary vascular remodeling that could be validated in a larger cohort of Group 3 PH patients
Such a signature could then be tested in clinical trials in Group 3 PH. These studies will have an important positive impact because they lay the foundation for a precision medicine strategy in Group 3 PH through the identification of potential responders and non-responders to PAH-specific therapies
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start8 Nov 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bastiaan Driehuys
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bastiaan Driehuys, Duke University
- Investigators
- Sudarshan Rajagopal, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778046
- Sponsor's protocol ID
- Pro00106221
- Acronym
- PH SOLAR
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2021
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining a Noninvasive Signature for Pulmonary Vascular Remodeling in Group 3 PH
- ClinicalTrials.gov ID
- NCT04778046
- Acronym / sponsor ID
- PH SOLAR / Pro00106221
- Keywords
- Lung Transplant, Group 3 PH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bastiaan DriehuysUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this study is to develop a noninvasive signature for pulmonary vascular remodeling in Group 3 PH patients, using hyperpolarized 129Xe magnetic resonance imaging (129Xe MRI). Such a signature may identify Group 3 PH responders to PAH-specific therapies. PAH's unique 129Xe MRI signature has been shown in previous studies. Past studies have lacked a pathologic "ground truth" correlate of these signatures, which could be provided by comparing them with the pathology of lung explant tissue from patients who have undergone a lung transplant. This signature could be validated in a cohort of patients with Group 3 PH in future studies.
Detailed description
The objective of this study is to identify a 129Xe MRI signature associated with PAH-like pulmonary vascular remodeling, consisting of plexiform arteriopathy, smooth muscle cell proliferation, and vascular fibrosis, in IPF and COPD that could be used to identify potential responders vs non-responders to PAH-specific therapies. The central hypothesis is that similar mechanisms and pathways underlie pulmonary vascular remodeling in IPF-PH, COPD-PH, and PAH. However, only a subset of Group 3 PH patients display remodeling consistent with PAH, resulting in responder vs. non-responder phenotypes when treated with PAH-specific therapies. In preliminary studies of subjects treated with Tyvaso, The study team has observed distinct 129Xe MRI signatures at baseline and with therapy depending on patients' underlying lung function. Consistent with this, recent studies using single-cell RNA sequencing (scRNAseq) of the pulmonary vasculature in IPF have demonstrated changes consistent with vascular remodeling.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PAH: | Experimental | Drug: Hyperpolarized 129XeClinical 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. |
| COPD-noPH | Experimental | Drug: Hyperpolarized 129XeClinical diagnosis of COPD in the absence of precapillary PH. |
| COPD-PH | Experimental | Drug: Hyperpolarized 129XeClinical diagnosis of COPD with precapillary PH |
| IPF-noPH | Experimental | Drug: Hyperpolarized 129XeClinical diagnosis of IPF in the absence of precapillary PH |
| IPF-PH | Experimental | Drug: Hyperpolarized 129XeClinical diagnosis of IPF with precapillary PH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years' old
- Be on the lung transplant waiting list at Duke University Medical Center.
- PH as defined by RHC - mPAP > 20 mmHg, PVR > 3 WU, PCWP < 15 mmHg
- Groups defined as:
- PAH: 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.
Key exclusion criteria (9 listed)
- Moderate to severe heart disease (LVEF < 45% or severe LV Hypertrophy).
- Sarcoidosis.
- Active cancer.
- Sickle cell anemia.
- Liver disease (Childs-Pugh class C).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized 129XeAlso: Xe MRIEach xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC), | Drug | COPD-PH, COPD-noPH, IPF-PH, IPF-noPH, PAH: |
Primary outcome
a pathology-based 129Xe MRI noninvasive signature of pulmonary vascular remodeling that could be validated in a larger cohort of Group 3 PH patients
Time frame: Day 1
Such a signature could then be tested in clinical trials in Group 3 PH. These studies will have an important positive impact because they lay the foundation for a precision medicine strategy in Group 3 PH through the identification of potential responders and non-responders to PAH-specific therapies
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sudarshan Rajagopal, MD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperpolarized 129Xe in people with Interstitial Lung Disease and COPD, run by Bastiaan Driehuys at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Salazar (+1 919 660 2026, claudia.salazar@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a pathology-based 129Xe MRI noninvasive signature of pulmonary vascular remodeling that could be validated in a larger cohort of Group 3 PH patients (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.