PET Image in PAH Patients

NCT05452889 | Recruiting Early Phase 1 FDA Drug

• 3 other identifiers: STUDY21050035PHAB Level 4 award 2021R01HL124021
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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

Keywords

Pulmonary hypertension; Early diagnoses; Non invasive

Outcome Measures

Primary Outcomes (1)

• SUV or image-based threshold of 18F-FGNnon-diseased controls

  Regional \[F-18\] fluoroglutamine (18F-FGN) utilization will be measured as standardized uptake values (SUV) of 18F-FGN in right ventricle wall, left ventricle wall, and perivascular tissue within the lung parenchyma.

  90 minutes

Study Arms (1)

18F-FGLN PET Imaging

EXPERIMENTAL

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

Diagnostic Test: 18F-FGLN PET Imaging; Drug: (18F)FPGLU

Interventions

18F-FGLN PET Imaging DIAGNOSTIC_TEST

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-FGLN PET Imaging

(18F)FPGLU DRUG

\[F-18\]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.

18F-FGLN PET Imaging

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cases:
• Smoking
• Pregnant/ breast feeding women
• Children under 18
• Inability to read and understand the informed consent
• History of CT contrast allergy
• Inability to lie down for long period of time
• Having claustrophobic
• History of radiation exposure at workplace
• Consuming more than 2-3 alcoholic drinks a week
• Working previously in any of the following "cool miner, painter, iron miner, Mill worker, asbestos, insulation/heat resistance materials, sand"
• Any medical conditions involving the heart or lungs that would make participation in the study unsafe in the opinion of the PI.
• Controls:
• Smoking
• Pregnant/ breast feeding women

Sponsors & Collaborators

• Stephen Y. Chan: lead
• Bayer: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Montefiore Hospital Clinical and Translational Research Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Disease

Interventions

N-(2-fluoropropionyl)glutamic acid

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Chan

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yassmin Al Aaraj

CONTACT

14126479227; yaa29@pitt.edu

Stephen Chan

CONTACT

chansy@upmc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: July 11, 2022
• Study Start: July 11, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will available starting 6 months after publication
• Access Criteria: The Comprehensive Pulmonary Hypertension Program and Comprehensive lung center shall require secondary investigators to obtain regulatory approval prior its provision of de-identified information to the secondary investigators

Locations

US (1)