NCT05452889 · Stephen Y. Chan
PET Image in PAH Patients
What this study is about
Pulmonary arterial hypertension (PAH) is mortal disease affecting the blood vessels of the lung. Despite its morbid prognosis, PAH is often misdiagnosed or ignored, with an average time of 44 months between onset of symptoms to diagnosis and substantial progression of disease severity.
View original scientific description
Pulmonary arterial hypertension (PAH) is mortal disease affecting the blood vessels of the lung. Despite its morbid prognosis, PAH is often misdiagnosed or ignored, with an average time of 44 months between onset of symptoms to diagnosis and substantial progression of disease severity. Therefore, a pressing need exists to develop non-invasive diagnostic imaging tools, particularly that can detect early disease stages. Efforts have been made to develop such imaging capabilities through platform development of echocardiography, cardiac MRI, chest computed tomography (CT), and positron emission tomography (PET), among others. While some have demonstrated promise, few have shown a precise ability to offer disease quantifications of the diseased lung and vasculature itself, to detect early stages of disease, and to reflect alterations of the lung, vasculature, and right ventricle that reflect the molecular origins of this disease. \[F-18\]FGln has been previously utilized in oncology studies as a non-invasive in vivo imaging biomarker of tumor glutamine flux and metabolism. Our preliminary in vivo pre-clinical rodent studies demonstrated that \[F-18\]FGln demonstrated increased uptake in diseased pulmonary vessels and the right ventricle in a rodent model of PAH. The proposed research study will provide preliminary evidence of the potential to utilize \[F-18\]FGln as a non-invasive imaging biomarker of glutamine flux and metabolism across a range of PAH subjects.
Interventions
DIAGNOSTIC_TEST
18F-FGLN PET Imaging
PET/CT Imaging: The study visit will take around 3-4 hours, the duration of PET will be around 90 minutes. Women should have negative pregnancy test prior to the study. An intravenous catheter will be placed in the subject's opposite arm, which will be used for radiotracer administration. A low-dose helical CT scan will be performed during a \~15 sec inspiratory breath hold and used for CT-based attenuation correction of PET emission data and as an anatomical reference for image analyses. Participants will be retained in the PET facility following the PET scan to promote urination to increase elimination of the radiotracer.
DRUG
(18F)FPGLU
\[F-18\]FGln is a natural glutamine derivative was synthesized to explore its potential application of imaging glutamine uptake for cancer diagnosis. The proposed research study will provide preliminary evidence of the potential to utilize \[F-18\]FGln as a non-invasive imaging biomarker of glutamine flux and metabolism across a range of PAH subjects.
Primary outcome measures
SUV or image-based threshold of 18F-FGNnon-diseased controls
Time frame: 90 minutes
Regional \[F-18\] fluoroglutamine (18F-FGN) utilization will be measured as standardized uptake values (SUV) of 18F-FGN in right ventricle wall, left ventricle wall, and perivascular tissue within the lung parenchyma.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age between 18-75 years old
- Confirmed diagnosis of SSc-PAH / SSc-eiPAH/IPAH/ by right heart catheterization. And Scleroderma with no PAH confirmand by echo. Controls:
- Age between 18-75 years old
- Individuals who are at low risk for current or future cardiovascular or pulmonary symptoms or diseases
Exclusion criteria
- Pregnant/ breast feeding women
- Children under 18
- Inability to read and understand the informed consent
- History of CT contrast allergy
- Inability to lie down for long period of time
- Having claustrophobic
- History of radiation exposure at workplace
- Consuming more than 2-3 alcoholic drinks a week
- Working previously in any of the following "cool miner, painter, iron miner, Mill worker, asbestos, insulation/heat resistance materials, sand"
- Any medical conditions involving the heart or lungs that would make participation in the study unsafe in the opinion of the PI. Controls:
- Pregnant/ breast feeding women
- Children under 18
- Inability to read and understand the informed consent
- History of CT contrast allergy.
- Inability to lie down for long period of time
- Having claustrophobic
- History of radiation exposure at workplace
- Consuming more than 2-3 alcoholic drinks a week
- Working previously in any of the following "coal miner, painter, iron miner, Mill worker, asbestos, insulation/heat resistance materials, sand"
- Any medical conditions involving the heart or lungs or that would make participation in the study unsafe in the opinion of the PI.
- Family history of Pulmonary Hypertension or Scleroderma
Where
- Pittsburgh, Pennsylvania
Collaborators
Bayer, National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 21, 2026 · Source of record for eligibility and locations