What is the mechanism of action of this treatment?

Common treatments for Pulmonary Arterial Hypertension (PAH) include phosphodiesterase-5 inhibitors (PDE5Is) like sildenafil and tadalafil, which work by relaxing pulmonary blood vessels to reduce resistance and improve blood flow. Endothelin receptor antagonists (ERAs) such as bosentan block endothelin, a substance that constricts blood vessels, thereby lowering blood pressure in the lungs. Prostacyclin analogs like epoprostenol dilate blood vessels and inhibit platelet aggregation. These treatments are crucial for managing PAH as they help alleviate symptoms, improve exercise capacity, and slow disease progression. Non-invasive imaging biomarkers like [F-18]FGln are being explored to monitor glutamine metabolism in PAH, offering potential for early detection and assessment of treatment response.

What side effects are associated with this type of intervention?

Common treatments for Pulmonary Arterial Hypertension (PAH) include endothelin receptor antagonists (ERAs) such as bosentan and macitentan, which can cause hepatotoxicity and peripheral edema. Phosphodiesterase-5 inhibitors (PDE5Is) like sildenafil and tadalafil are associated with side effects such as headache, flushing, dyspepsia, and visual disturbances. Prostacyclin analogues like epoprostenol and treprostinil can lead to jaw pain, nausea, diarrhea, and flushing. These treatments aim to improve hemodynamics and exercise capacity but come with a range of potential adverse effects that need to be managed carefully.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Pulmonary Arterial Hypertension (PAH). Endothelin receptor antagonists (ERAs) such as bosentan, ambrisentan, and macitentan have been approved for their ability to delay disease progression and improve exercise capacity. Phosphodiesterase-5 inhibitors (PDE5Is) like sildenafil and tadalafil are also approved and are known to improve hemodynamic parameters and exercise tolerance. Additionally, prostacyclin analogs such as epoprostenol and treprostinil have been approved for their efficacy in improving symptoms and functional class in PAH patients. These treatments, while not directly related to the non-invasive imaging biomarker [F-18]FGln, represent the current landscape of FDA-approved therapies for PAH.

What other types of research exist?

Promising novel alternatives to [F-18]FGln for non-invasive imaging in PAH patients include [68Ga]FAPI-04, which has shown potential in imaging pulmonary artery remodeling in chronic thromboembolic pulmonary hypertension (CTEPH). Additionally, hybrid PET/MRI imaging combining metabolic and functional assessments of the right ventricle (RV) may offer comprehensive insights into PAH progression and treatment response.

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PET Imaging for Pulmonary Arterial Hypertension

Phase < 1

Recruiting

Led By Stephen Chan

Research Sponsored by Stephen Y. Chan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Controls: Age between 18-75 years old

Cases: Age between 18-75 years old

Must not have

Controls: History of radiation exposure at workplace

Cases: Inability to lie down for long period of time

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 minutes

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

[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.

What are the potential side effects?

As [F-18]FGln is used for imaging purposes and involves lying down in a scanner without medication administration like typical drugs, side effects are minimal but may include discomfort from staying still and potential reactions to the tracer substance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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I am between 18 and 75 years old.

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I have been diagnosed with a specific type of pulmonary hypertension or scleroderma without PAH, confirmed by heart catheterization.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been exposed to radiation at work.

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I cannot lie down for long periods.

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I cannot lie down for long periods.

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I am under 18 years old.

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I am under 18 years old.

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I have been exposed to radiation at work.

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My family has a history of Pulmonary Hypertension or Scleroderma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 18F-FGLN PET ImagingExperimental Treatment2 Interventions

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Pulmonary Arterial Hypertension (PAH) include phosphodiesterase-5 inhibitors (PDE5Is) like sildenafil and tadalafil, which work by relaxing pulmonary blood vessels to reduce resistance and improve blood flow. Endothelin receptor antagonists (ERAs) such as bosentan block endothelin, a substance that constricts blood vessels, thereby lowering blood pressure in the lungs. Prostacyclin analogs like epoprostenol dilate blood vessels and inhibit platelet aggregation. These treatments are crucial for managing PAH as they help alleviate symptoms, improve exercise capacity, and slow disease progression. Non-invasive imaging biomarkers like [F-18]FGln are being explored to monitor glutamine metabolism in PAH, offering potential for early detection and assessment of treatment response.

NMR-Based Metabolomic Analysis of Plasma in Patients with Adult Congenital Heart Disease and Associated Pulmonary Arterial Hypertension: A Pilot Study.Clinical trials in group 3 pulmonary hypertension.Efficacy and tolerability of pharmacological interventions for pulmonary arterial hypertension: A network meta-analysis.