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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

⁃ Cases:

• 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

Locations
United States
Pennsylvania
Montefiore Hospital Clinical and Translational Research Center
RECRUITING
Pittsburgh
Contact Information
Primary
Yassmin Al Aaraj
yaa29@pitt.edu
14126479227
Backup
Stephen Chan
chansy@upmc.edu
Time Frame
Start Date: 2022-07-11
Estimated Completion Date: 2026-12
Participants
Target number of participants: 71
Treatments
Experimental: 18F-FGLN PET Imaging
10.0 mCi of 18F-FGln will be injected intravenously as a slow bolus (20 sec)
Related Therapeutic Areas
Sponsors
Collaborators: Bayer, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Stephen Y. Chan

This content was sourced from clinicaltrials.gov