BridgeMD
New treatment option for Interstitial Lung Disease
Official title Pulmonary Hypertension SOLAR
ClinicalTrials.gov ID: NCT04778046
What this study is testing
What is Hyperpolarized 129Xe?
Hyperpolarized 129Xe is an investigational medicine, being studied as a potential treatment for interstitial lung disease.
Also referred to as Xe MRI.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.