Recruiting
Early Phase 1

F-18 FGln

Sponsor:

Stephen Y. Chan

Code:

NCT05452889

Conditions

Pulmonary Arterial Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

18F-FGLN PET Imaging

(18F)FPGLU

Study Details

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.

Conditions

Pulmonary Arterial Hypertension

Study ID

NCT05452889

Start date

Jul 11, 2022

Status verified date

Jan, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

71 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 18F-FGLN PET Imaging

10.0 mCi of 18F-FGln will be injected intravenously as a slow bolus (20 sec)

Interventions

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.

(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 measure

  • SUV or image-based threshold of 18F-FGNnon-diseased controls [ Time Frame: 90 minutes ]

Central Contacts and Locations

Central contacts

Yassmin Al Aaraj

14126479227yaa29@pitt.edu

Stephen Chan

chansy@upmc.edu

Locations

Montefiore Hospital Clinical and Translational Research Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

More Information

Sponsor

Stephen Y. Chan

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Keywords

  • Pulmonary hypertension
  • Early diagnoses
  • Non invasive

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stephen Y. Chan on 2026-01-21.