Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT05452889

PET Image in PAH Patients

Led by Stephen Y. Chan · Updated on 2026-01-21

71

Participants Needed

1

Research Sites

238 weeks

Total Duration

On this page

Sponsors

S

Stephen Y. Chan

Lead Sponsor

B

Bayer

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

PET Image in PAH Patients

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years old
  • Confirmed diagnosis of Scleroderma-PAH, Scleroderma exercise induced PAH, or Idiopathic PAH by right heart catheterization
  • Scleroderma without PAH confirmed by echocardiogram
  • For controls: Age between 18 and 75 years old
  • Controls must be at low risk for current or future cardiovascular or pulmonary symptoms or diseases
Not Eligible

You will not qualify if you...

  • Current smoking
  • Pregnant or breastfeeding women
  • Children under 18 years old
  • Inability to read and understand the informed consent
  • History of allergy to CT contrast
  • Inability to lie down for a long period of time
  • Claustrophobia
  • History of radiation exposure at the workplace
  • Consuming more than 2-3 alcoholic drinks per week
  • Previous work as coal miner, painter, iron miner, mill worker, asbestos or insulation/heat resistance materials handler, or sand exposure
  • Any heart or lung medical conditions making participation unsafe in the opinion of the principal investigator
  • For controls: Family history of Pulmonary Hypertension or Scleroderma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Montefiore Hospital Clinical and Translational Research Center

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

Y

Yassmin Al Aaraj

CONTACT

S

Stephen Chan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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