PET Imaging for Pulmonary Arterial Hypertension

Overseen by Stephen Chan

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Stephen Y. Chan

Disqualifiers: Smoking, Pregnancy, Heart conditions, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses a special PET scan with a tracer called 18F-FGln to study how a substance called glutamine is taken up in the lungs and heart of patients with different types of pulmonary arterial hypertension (PAH). The goal is to see if this method can help detect early stages of PAH and understand its progression. The study includes patients with various forms of PAH and healthy individuals for comparison.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

How does PET imaging differ from other treatments for pulmonary arterial hypertension?

PET imaging for pulmonary arterial hypertension is unique because it uses a special type of scan to visualize and measure glucose uptake in the lungs and heart, helping to understand the disease's underlying mechanisms and track changes over time. Unlike traditional treatments that focus on managing symptoms, PET imaging provides a non-invasive way to assess the disease's progression and response to therapies. ^{1 2 3 4 5}

Research Team

Stephen Chan

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults aged 18-75 with confirmed PAH or at low risk of heart/lung diseases. It's not for pregnant/breastfeeding women, smokers, those with certain job exposures, CT contrast allergies, claustrophobia, excessive alcohol consumption, or conditions making the study unsafe.

Inclusion Criteria

I am at low risk for heart or lung problems now or in the future.

I am between 18 and 75 years old.

I am between 18 and 75 years old.

Exclusion Criteria

You have claustrophobia.

I have been exposed to radiation at work.

I cannot lie down for long periods.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET Imaging

Participants undergo 18F-FGln PET imaging to measure glutamine uptake

1 day

1 visit (in-person)

Follow-up

A follow-up telephone call will be made to subjects to inquire about any adverse events

1-7 days

Treatment Details

Interventions

• (18F)FGln (Radiopharmaceutical)

Trial Overview [F-18]FGln PET imaging is being tested to see if it can non-invasively detect early stages of PAH by measuring glutamine metabolism in the lungs and heart. This could help diagnose PAH more quickly than current methods.

Participant Groups

Group I: 18F-FGLN PET Imaging Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Stephen Y. Chan

Lead Sponsor

Trials

1

Recruited

70+

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

Findings from Research

Dynamic 18FLT positron emission tomography (PET) imaging revealed significantly increased lung 18FLT phosphorylation in patients with idiopathic pulmonary arterial hypertension (IPAH), indicating heightened cellular proliferation compared to controls, which could serve as a noninvasive biomarker for tracking disease progression.

The study demonstrated that 18FLT uptake correlates with markers of vascular remodeling and proliferation, and importantly, this uptake decreased in response to antiproliferative treatments, suggesting that 18FLT PET could be useful for assessing treatment efficacy in IPAH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3'-Deoxy-3'-[18F]Fluorothymidine Positron Emission Tomography Depicts Heterogeneous Proliferation Pathology in Idiopathic Pulmonary Arterial Hypertension Patient Lung. Ashek, A., Spruijt, OA., Harms, HJ., et al.[2022]

In a study of 27 patients with pulmonary hypertension (PH), increased FDG accumulation in the right ventricular (RV) free wall was found to be a significant prognostic indicator, with higher levels correlating with clinical worsening and mortality.

Patients with a corrected RV standardized uptake value (cRV-SUV) of 8.3 or higher had a poorer prognosis, suggesting that FDG-PET imaging could be a valuable tool for predicting outcomes in PH patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced [18F]fluorodeoxyglucose accumulation in the right ventricular free wall predicts long-term prognosis of patients with pulmonary hypertension: a preliminary observational study. Tatebe, S., Fukumoto, Y., Oikawa-Wakayama, M., et al.[2016]

In a study of 109 patients with end-stage pulmonary disease, increased [F]FDG uptake in the lungs and heart was significantly associated with the presence and severity of pulmonary hypertension (PH), indicating that PET imaging can effectively visualize these changes.

The study found that higher glucose metabolism in the pulmonary arteries correlates with increased mean pulmonary artery pressure and pulmonary vascular resistance, suggesting that [F]FDG-PET imaging could provide insights into the underlying mechanisms of PH as a proliferative disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thoracic [18F]fluorodeoxyglucose uptake measured by positron emission tomography/computed tomography in pulmonary hypertension. Frille, A., Steinhoff, KG., Hesse, S., et al.[2021]

In a study of 175 patients with suspected cardiac sarcoidosis, increased 18F-FDG uptake in the pulmonary artery (PA) was significantly associated with higher pulmonary artery pressures, indicating a potential link to pulmonary hypertension (PH).

Among patients who underwent right heart catheterization, 90% of those with PA 18F-FDG uptake had PH, compared to only 45% in those without uptake, suggesting that PET imaging could be a useful tool for identifying patients at risk for PH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary Artery 18F-Fluorodeoxyglucose Uptake by PET/CMR as a Marker of Pulmonary&#160;Hypertension in Sarcoidosis. Maier, A., Liao, SL., Lescure, T., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

3'-Deoxy-3'-[18F]Fluorothymidine Positron Emission Tomography Depicts Heterogeneous Proliferation Pathology in Idiopathic Pulmonary Arterial Hypertension Patient Lung. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Enhanced [18F]fluorodeoxyglucose accumulation in the right ventricular free wall predicts long-term prognosis of patients with pulmonary hypertension: a preliminary observational study. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Thoracic [18F]fluorodeoxyglucose uptake measured by positron emission tomography/computed tomography in pulmonary hypertension. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Pulmonary Artery 18F-Fluorodeoxyglucose Uptake by PET/CMR as a Marker of Pulmonary&#160;Hypertension in Sarcoidosis. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

Assessment of lung glucose uptake in patients with systemic lupus erythematosus pulmonary arterial hypertension: a quantitative FDG-PET imaging study. [2022]