RecruitingEarly Phase 1NCT05452889

PET Image in PAH Patients

Utilizing 18F-fluoroglutamine PET Imaging in Patients With Pulmonary Arterial Hypertension


Sponsor

Stephen Y. Chan

Enrollment

71 participants

Start Date

Jul 11, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study uses special PET scan imaging to study blood vessel and lung abnormalities in people with pulmonary arterial hypertension (PAH) — a condition where blood pressure in the lungs becomes dangerously high — including PAH caused by scleroderma (a connective tissue disease). It also enrolls healthy volunteers for comparison. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with PAH (confirmed by right heart catheterization), including forms linked to scleroderma - OR you are a healthy volunteer with no known heart or lung conditions (for the control group) **You may NOT be eligible if...** - You are a current smoker - You are pregnant or breastfeeding - You have a history of allergy to CT contrast dye - You are unable to lie flat for extended periods or have claustrophobia - You drink more than 2–3 alcoholic drinks per week - You have had significant occupational exposure to dust or chemicals (mining, painting, asbestos, etc.) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST18F-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.


Locations(1)

Montefiore Hospital Clinical and Translational Research Center

Pittsburgh, Pennsylvania, United States

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NCT05452889


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