PET Image in PAH Patients

RECRUITING

I'm interested ...!!

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.

Conditions:

🦠 Pulmonary Arterial Hypertension

🗓️ Study Start (Actual) 11 July 2022

🗓️ Primary Completion (Estimated) December 2024

✅ Study Completion (Estimated) December 2025

👥 Enrollment (Estimated) 71

🔬 Study Type INTERVENTIONAL

📊 Phase EARLY_PHASE1

Locations:

📍 Pittsburgh, Pennsylvania, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

Cases:
1. Age between 18-75 years old
2. Confirmed diagnosis of SSc-PAH / SSc-eiPAH/IPAH/ by right heart catheterization. And Scleroderma with no PAH confirmand by echo.
Controls:
1. Age between 18-75 years old
2. Individuals who are at low risk for current or future cardiovascular or pulmonary symptoms or diseases

Exclusion Criteria:

Cases:
1. Smoking
2. Pregnant/ breast feeding women
3. Children under 18
4. Inability to read and understand the informed consent
5. History of CT contrast allergy
6. Inability to lie down for long period of time
7. Having claustrophobic
8. History of radiation exposure at workplace
9. Consuming more than 2-3 alcoholic drinks a week
10. Working previously in any of the following "cool miner, painter, iron miner, Mill worker, asbestos, insulation/heat resistance materials, sand"
11. Any medical conditions involving the heart or lungs that would make participation in the study unsafe in the opinion of the PI.
Controls:
1. Smoking
2. Pregnant/ breast feeding women
3. Children under 18
4. Inability to read and understand the informed consent
5. History of CT contrast allergy.
6. Inability to lie down for long period of time
7. Having claustrophobic
8. History of radiation exposure at workplace
9. Consuming more than 2-3 alcoholic drinks a week
10. Working previously in any of the following "coal miner, painter, iron miner, Mill worker, asbestos, insulation/heat resistance materials, sand"
11. Any medical conditions involving the heart or lungs or that would make participation in the study unsafe in the opinion of the PI.
12. Family history of Pulmonary Hypertension or Scleroderma

Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 9 June 2022
First Submitted that Met QC Criteria 7 July 2022
First Posted 11 July 2022

Study Record Updates

Last Update Submitted that Met QC Criteria 15 July 2024
Last Update Posted 17 July 2024
Last Verified July 2024