PET Imaging for Pulmonary Arterial Hypertension

Overseen By Stephen Chan

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Stephen Y. Chan

Disqualifiers: Smoking, Pregnancy, Heart conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

71 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new method for detecting pulmonary arterial hypertension (PAH), a serious condition affecting the blood vessels in the lungs. Researchers are testing a special imaging technique using a compound called \[F-18\]FGln (Fluorine-18 glutamine), which may help identify early stages of PAH by revealing changes in the lungs and heart. This could make diagnosing PAH quicker and easier. Individuals with scleroderma and PAH or related conditions confirmed through specific heart tests might be suitable for the trial. As an Early Phase 1 trial, this research focuses on understanding how this new imaging method works in people, offering participants a chance to contribute to groundbreaking advancements in PAH detection.

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.

What prior data suggests that this PET imaging technique is safe for pulmonary arterial hypertension patients?

Research has shown that (18F)FGln, a substance used in PET scans, has been tested for safety in animal studies with rats. These studies found that (18F)FGln was absorbed by damaged lung vessels and the right side of the heart in rats with pulmonary arterial hypertension (PAH). Although limited information exists from human studies, these early findings suggest that the substance targets areas affected by PAH.

Since this trial is in an early stage, researchers are still learning about the safety of (18F)FGln in humans. Early trials mainly focus on identifying any side effects and understanding how the body processes the treatment, with safety being closely monitored. So far, existing studies have not reported clear negative effects in humans. However, more research is needed to confirm its safety and effectiveness for people with PAH. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 18F-FGln PET Imaging for pulmonary arterial hypertension because it offers a new way to visualize and understand the disease. Unlike traditional methods that focus on treating symptoms, this approach uses a radioactive tracer to provide detailed images of the lungs, potentially allowing for earlier and more accurate diagnosis. This innovative imaging technique could reveal insights into how the disease progresses, leading to more targeted and effective treatments in the future.

What evidence suggests that this PET imaging technique is effective for pulmonary arterial hypertension?

Research has shown that \[F-18\]FGln could be a useful tool for imaging pulmonary arterial hypertension (PAH) without requiring surgery. In rodent studies, \[F-18\]FGln accumulated more in the diseased lung vessels and the right side of the heart, suggesting it might help identify early signs of PAH. This is crucial because PAH often goes unnoticed until it becomes severe. While \[F-18\]FGln is primarily used in cancer research to track the body's use of glutamine, an amino acid, these early findings offer hope that it might also detect PAH early by revealing changes in the lungs. Further research is necessary to determine its effectiveness in humans. Participants in this trial will undergo \[F-18\]FGln PET imaging to further explore its potential in detecting PAH. ^{3 5 6 7 8}

Who Is on the Research Team?

Stephen Chan

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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

Exclusion Criteria

You have claustrophobia.

I have been exposed to radiation at work.

I cannot lie down for long periods.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• (18F)FGln

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 involving 14 SLE-PAH patients, 20 IPAH patients, and 10 healthy volunteers, lung FDG uptake was significantly higher in SLE-PAH patients compared to healthy individuals, indicating increased metabolic activity associated with pulmonary vascular pathology.

Increased lung FDG uptake in SLE-PAH patients correlated with higher disease activity scores (SLEDAI) and lower levels of plasma complement proteins C3 and C4, suggesting that FDG-PET imaging could serve as a useful marker for assessing disease activity in these patients.

NCBI (Pubmed)

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. Wang, L., Xiong, C., Li, M., et al.[2022]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05452889

Study Details | NCT05452889 | PET Image in PAH Patients Our preliminary in vivo pre-clinical rodent studies demonstrated that [F-18]FGln demonstrated increased uptake in diseased pulmonary vessels and the right ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8256252/

Application of [18F]FLT‐PET in pulmonary arterial ... This study sought to validate 18 FLT‐PET in an expanded cohort of pulmonary arterial hypertension patients in comparison to matched healthy controls.

3. withpower.com withpower.com/trial/early-phase-1-pulmonary-arterial-hypertension-8-2022-f1c0e?lat=34.60184&lng=-117.81218

PET Imaging for Pulmonary Arterial Hypertension The study demonstrated that 18FLT uptake correlates with markers of vascular remodeling and proliferation, and importantly, this uptake decreased in response to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11273098/

Early detection of pulmonary arterial hypertension through ... Our study provides a compelling evidence for the potential utility of the innovative [ 18 F]VEGFR PET tracer, in non‐invasively detecting early signs of PAH, ...

5. researchgate.net researchgate.net/publication/379829843_18F-fluorodeoxyglucose_uptake_by_positron_emission_tomography_in_patients_with_IPAH_and_CTEPH

(PDF) (18)F-fluorodeoxyglucose uptake by positron ... The present study aimed to investigate the role of PET/CT imaging of patients with IPAH and CTEPH as an alternative diagnosis method.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38618292/

(18)F-fluorodeoxyglucose uptake by positron emission ... Increased RV FDG and RA FDG uptakes predicts the presence of pulmonary hypertension and correlates with mPAP and RAP, respectively, which are ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3326289/

Lung 18F-Fluorodeoxyglucose Positron Emission ... The FDG signal increases early in the disease, when PAH is mild, and is reduced by effective therapies (dichloroacetate and imatinib), suggesting that lung FDG- ...

8. researchgate.net researchgate.net/publication/362009641_Evaluation_of_Lung_Glucose_Uptake_with_Fluorine-18_Fluorodeoxyglucose_Positron_Emission_TomographyCT_in_Patients_with_Pulmonary_Arterial_Hypertension_and_Pulmonary_Hypertension_Due_to_Left_Heart_Disea?_tp=eyJjb250ZXh0Ijp7InBhZ2UiOiJzY2llbnRpZmljQ29udHJpYnV0aW9ucyIsInByZXZpb3VzUGFnZSI6bnVsbCwic3ViUGFnZSI6bnVsbH19

Evaluation of Lung Glucose Uptake with Fluorine-18 ... Conclusion: PAH is associated with increased lung FDG uptake indicating increased glucose utilization in the lung. This may represent metabolic ...