Using PET imaging to detect early pulmonary arterial hypertension

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

This study is testing a new imaging method to see if it can help detect early signs of pulmonary arterial hypertension in patients before it gets worse.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 71 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT05452889 on ClinicalTrials.gov

What this trial studies

This study aims to utilize 18F-fluoroglutamine (18F-FGln) PET imaging to assess glutamine uptake in patients diagnosed with pulmonary arterial hypertension (PAH) compared to healthy controls. The objective is to develop a non-invasive imaging biomarker that can detect early stages of PAH, which is often misdiagnosed and leads to significant disease progression. The research team, consisting of experts in the field, will conduct in-human imaging to quantify metabolic changes associated with PAH. This pilot experiment seeks to establish the potential of 18F-FGln as a diagnostic tool for early intervention.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 with a confirmed diagnosis of scleroderma-related PAH or idiopathic PAH.

Not a fit: Patients with a history of smoking, certain medical conditions affecting the heart or lungs, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of pulmonary arterial hypertension, improving patient outcomes.

How similar studies have performed: While some studies have explored imaging techniques for PAH, the specific use of 18F-FGln PET imaging for this purpose is novel and has not been extensively tested.

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

Where this trial is running

Pittsburgh, Pennsylvania

• Montefiore Hospital Clinical and Translational Research Center — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Stephen Chan — University of Pittsburgh
• Study coordinator: Yassmin Al Aaraj

Conditions Pulmonary Arterial Hypertension; Pulmonary hypertension; Early diagnoses; Non invasive