NCT05452889 PET Image in PAH Patients
| NCT ID | NCT05452889 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Stephen Y. Chan |
| Condition | Pulmonary Arterial Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 71 participants |
| Start Date | 2022-07-11 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 71 participants in total. It began in 2022-07-11 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Stephen Chan
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05452889 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pulmonary Arterial Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05452889 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05452889 currently recruiting?
Yes, NCT05452889 is actively recruiting participants. Contact the research team at yaa29@pitt.edu for enrollment information.
Where is the NCT05452889 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT05452889 clinical trial?
NCT05452889 is sponsored by Stephen Y. Chan. The principal investigator is Stephen Chan at University of Pittsburgh. The trial plans to enroll 71 participants.