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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 belowSelect...
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:Select...
I have been exposed to radiation at work.
Select...
I cannot lie down for long periods.
Select...
I cannot lie down for long periods.
Select...
I am under 18 years old.
Select...
I am under 18 years old.
Select...
I have been exposed to radiation at work.
Select...
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
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)
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.
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.
Find a Location
Who is running the clinical trial?
BayerIndustry Sponsor
2,276 Previous Clinical Trials
25,540,644 Total Patients Enrolled
28 Trials studying Pulmonary Arterial Hypertension
6,670 Patients Enrolled for Pulmonary Arterial Hypertension
Stephen Y. ChanLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,942 Previous Clinical Trials
47,793,167 Total Patients Enrolled
27 Trials studying Pulmonary Arterial Hypertension
3,160 Patients Enrolled for Pulmonary Arterial Hypertension
Stephen ChanPrincipal InvestigatorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have claustrophobia.I have been exposed to radiation at work.I cannot lie down for long periods.You have had an allergic reaction to CT scan dye in the past.I cannot lie down for long periods.I am at low risk for heart or lung problems now or in the future.I am under 18 years old.You drink more than 2-3 alcoholic drinks per week.I am between 18 and 75 years old.You have worked in any of the occupations listed in the 'Occupation Exposure History' section.I am under 18 years old.You are a smoker.You have had an allergic reaction to CT scan dye in the past.You are a smoker.I have been exposed to radiation at work.You drink more than 2-3 alcoholic drinks per week.You have worked in any of the occupations listed in the 'Occupation Exposure History' section.You are afraid of small, enclosed spaces.I am between 18 and 75 years old.I have been diagnosed with a specific type of pulmonary hypertension or scleroderma without PAH, confirmed by heart catheterization.If you have any heart, lung, or other medical conditions that the principal investigator thinks would make it unsafe for you to be in the study.My family has a history of Pulmonary Hypertension or Scleroderma.
Research Study Groups:
This trial has the following groups:- Group 1: 18F-FGLN PET Imaging
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.