PET/MR Imaging for Pulmonary Hypertension

Overseen By Patrick Veit-Haibach, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Pregnancy, Breastfeeding, MR contraindication, others

Stay on Your Current Meds You can continue your current medications while participating

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how PET/MR (Positron Emission Tomography/Magnetic Resonance Imaging) can identify signs of heart and lung problems, such as pulmonary hypertension, in individuals receiving radiotherapy for chest cancer. The trial will use PET/MR scans with a tracer called 18F-FDG to detect early changes that might lead to these issues. Suitable participants have confirmed chest cancer treated with radiotherapy that could affect the heart. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future diagnostic methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that PET/MR with 18F-FDG is safe for imaging in pulmonary hypertension?

Research has shown that PET/MR imaging with 18F-FDG is generally safe and well-tolerated by patients. This imaging method effectively evaluates various medical conditions, such as heart function and blood flow. The procedure includes a PET scan, which helps doctors assess how organs and tissues are functioning.

Although using 18F-FDG in PET scans is common, mild side effects from radiation exposure may occur. However, radiation levels remain low to minimize risks. The safety of PET/MR imaging has been demonstrated in other applications, such as evaluating heart diseases, supporting its use for studying pulmonary hypertension (high blood pressure in the lungs).

Overall, past studies suggest that PET/MR imaging with 18F-FDG is a safe option for patients, with no significant adverse events reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of PET/MR imaging with 18F-FDG for pulmonary hypertension because it offers a unique way to visualize and understand the condition. Unlike current treatments that primarily focus on managing symptoms and improving blood flow, this imaging technique could allow doctors to see metabolic changes in the heart and lungs in real time. By using 18F-FDG, a radioactive glucose compound, PET/MR imaging provides a clearer picture of how the disease is affecting the body at a cellular level, potentially leading to earlier and more personalized treatment strategies.

What evidence suggests that PET/MR imaging is effective for pulmonary hypertension?

Research has shown that PET/MR imaging, using a substance called 18F-FDG, can help identify pulmonary hypertension, or high blood pressure in the lungs. One study found that the amount of 18F-FDG absorbed by the pulmonary artery relates to the blood pressure there. This imaging can reveal changes in glucose use, which is crucial for understanding disease progression. Another study discovered that higher levels of 18F-FDG in the lungs might indicate more active disease, but these levels can decrease with effective treatment. These findings suggest that PET/MR with 18F-FDG may aid in monitoring and understanding pulmonary hypertension, potentially leading to better management of the condition. Participants in this trial will undergo PET/MR imaging with 18F-FDG to explore its effectiveness in assessing pulmonary hypertension. ^{6 7 8 9 10}

Who Is on the Research Team?

Patrick Veit-Haibach, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a diagnosed thoracic cancer intended to be treated with radiotherapy that also affects the heart. They must consent to PET/MR imaging, blood tests, and not be pregnant if of child-bearing age.

Inclusion Criteria

I am planning to undergo radiation therapy that will affect my heart.

Ability to provide written informed consent to participate in the study (for all components of the trial: imaging with cardiac PET/MR, blood sampling for plasma metabolomics and circulating DNA).

My chest tumor will be treated with radiation or chemo.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Radiotherapy Assessment

PET/MR scans and metabolomic markers assessment conducted 4 weeks prior to radiotherapy

4 weeks

1 visit (in-person)

Radiotherapy

Participants undergo radiotherapy treatment for thoracic cancer

6-10 weeks

Post-Radiotherapy Assessment

PET/MR scans and metabolomic markers assessment conducted 6-10 weeks after completion of radiotherapy

6-10 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in FDG uptake and cardiopulmonary function up to 16 weeks after radiotherapy

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PET/MR with 18F-FDG

Trial Overview The study is testing how well PET/MR imaging combined with blood analysis can predict heart and lung problems after radiotherapy in patients at risk of developing pulmonary hypertension (high blood pressure in lungs).

How Is the Trial Designed?

Group I: One arm / exploratory study Experimental Treatment 1 Intervention

Injection of 18F-FDG.The 18F-FDG cardiac PET-MR scanning visit will take up to 1.5 hours.

PET/MR with 18F-FDG is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as PET/MRI with 18F-FDG for:

• Diagnostic imaging for various cancers and conditions, including pulmonary hypertension

Approved in United States as PET/MRI with 18F-FDG for:

• Diagnostic imaging for various cancers and conditions, including pulmonary hypertension

Approved in Canada as PET/MRI with 18F-FDG for:

• Diagnostic imaging for various cancers and conditions, including pulmonary hypertension

Approved in Japan as PET/MRI with 18F-FDG for:

• Diagnostic imaging for various cancers and conditions, including pulmonary hypertension

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Cardiac MRI is a powerful tool for early detection and assessment of pulmonary hypertension (PH), providing detailed information on the morphology and hemodynamics of the pulmonary artery and right ventricle, which is crucial for improving patient outcomes.

New techniques in cardiac MRI, such as strain analysis and four-dimensional flow imaging, can identify early right ventricular dysfunction and advanced hemodynamics, potentially leading to better management and prognosis for patients with PH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac MRI in Pulmonary Hypertension: From Magnet to Bedside. Broncano, J., Bhalla, S., Gutierrez, FR., et al.[2021]

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]

Magnetic resonance imaging (MRI) demonstrated excellent diagnostic performance for pulmonary hypertension (PH), particularly with a sensitivity of 100% and specificity of 96.8% for chronic thromboembolic pulmonary hypertension (CTEPH), based on a study of 35 patients compared to right heart catheterization (RHC).

MRI also showed a strong correlation with hemodynamic parameters from RHC, especially in measuring pulmonary vascular resistance (r = 0.923), making it a promising non-invasive alternative for diagnosing PH without radiation exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric Magnetic Resonance Imaging in the Assessment of Pulmonary Hypertension: Initial Experience of a One-Stop Study. Meyer, GMB., Spilimbergo, FB., Altmayer, S., et al.[2019]

Combined PET/MRI is an innovative imaging technique that enhances the assessment of heart conditions by integrating functional and structural imaging, making it particularly useful for diagnosing complex cardiac issues like ischemic and non-ischemic cardiomyopathies.

This method shows great promise for evaluating systemic diseases and cardiac masses that are difficult to assess with traditional MRI, with cardiac sarcoidosis being highlighted as a key area where PET/MRI could significantly improve diagnosis and treatment monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical use of cardiac PET/MRI: current state-of-the-art and potential future applications. Krumm, P., Mangold, S., Gatidis, S., et al.[2018]

Integrated magnetic resonance imaging (MR) and positron emission tomography (PET) systems offer a promising approach for better understanding cancer by combining detailed anatomical images with metabolic information, potentially leading to improved disease assessment.

These hybrid systems can provide valuable insights into disease biology while exposing patients to lower radiation doses compared to traditional CT scans, although there are technical challenges and workflow considerations that need to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated whole body MR/PET: where are we? Yoo, HJ., Lee, JS., Lee, JM.[2018]

Cardiac PET/MRI is an advanced imaging technology that combines the strengths of PET's molecular imaging and MRI's soft tissue contrast, making it a promising tool for diagnosing various cardiovascular diseases.

This imaging method shows potential in diagnosing conditions like atherosclerosis, ischemic cardiomyopathy, nodular heart disease, and myocardial amyloidosis, which could enhance precision medicine in cardiovascular care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A review on cardiac positron emission tomography/magnetic resonance imaging in diagnosis of cardivascular diseases]. Chen, H., Wang, R., Wei, J., et al.[2023]

MRI is a powerful tool for diagnosing pulmonary hypertension (PH) as it can assess both cardiac and lung structures and functions in a single exam, making it more efficient than traditional methods.

Recent advancements in MRI techniques, such as hyperpolarized gas imaging and machine learning applications, show promise for improving the accuracy and effectiveness of PH diagnosis and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Cardiopulmonary MRI Assessment of Pulmonary Hypertension. Saunders, LC., Hughes, PJC., Alabed, S., et al.[2023]

Imaging techniques, particularly echocardiography and cardiac magnetic resonance (CMR) imaging, are essential for assessing the severity of pulmonary hypertension (PH) and evaluating right ventricular function noninvasively.

This review highlights the strengths and weaknesses of various imaging modalities, emphasizing their clinical utility in diagnosing and managing PH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging in the evaluation of pulmonary artery hemodynamics and right ventricular structure and function. Fakhri, AA., Hughes-Doichev, RA., Biederman, RW., et al.[2016]

In patients with pulmonary hypertension, increased FDG uptake in the right ventricle (RV) correlates with decreased RV function, indicating that higher FDG levels may reflect worsening heart performance.

The ratio of FDG uptake between the RV and left ventricle (SUVR/L) can independently predict right ventricular ejection fraction, suggesting it could be a valuable tool for assessing RV function in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ratio of (18)F-FDG activity uptake between the right and left ventricle in patients with pulmonary hypertension correlates with the right ventricular function. Yang, T., Wang, L., Xiong, CM., et al.[2016]

In a study of 46 patients with pulmonary hypertension (PH), late gadolinium enhancement (LGE) at ventricular insertion points (VIPs) was found in 42 patients, indicating a significant presence of myocardial changes associated with PH.

The paradoxical interventricular septum (IVS) motion index was identified as a strong predictor of LGE volume at VIPs, suggesting that altered motion rather than just elevated right ventricular pressure is a key factor in these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paradoxical interventricular septal motion as a major determinant of late gadolinium enhancement in ventricular insertion points in pulmonary hypertension. Sato, T., Tsujino, I., Ohira, H., et al.[2021]

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]

Cardiac magnetic resonance (CMR) imaging has become a crucial tool for diagnosing and predicting outcomes in pulmonary hypertension (PH), with established metrics that enhance risk stratification and treatment response assessment.

Emerging techniques like myocardial T1 mapping and strain analysis are showing promise in monitoring heart function and predicting mortality, while machine learning is being explored to improve the accuracy and automation of CMR assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Magnetic Resonance in Pulmonary Hypertension-an Update. Alabed, S., Garg, P., Johns, CS., et al.[2022]

Integrated (18)F-FDG PET/MR imaging significantly enhances the diagnostic accuracy for cardiac masses, achieving 100% sensitivity and 92% specificity when combining SUVmax thresholds with MR image interpretation.

The study involved 20 patients, revealing that malignant cardiac lesions had a much higher maximum standardized uptake value (SUVmax) compared to nonmalignant cases, indicating that SUVmax can be a reliable marker for differentiating between these types of masses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated 18F-FDG PET/MR imaging in the assessment of cardiac masses: a pilot study. Nensa, F., Tezgah, E., Poeppel, TD., et al.[2022]

In a study of 190 oncology patients, PET/MRI clarified indeterminate findings from PET/CT in 18 out of 31 cases, significantly improving diagnostic certainty by differentiating between infection/inflammation and malignancy.

PET/MRI demonstrated advantages over PET/CT by enhancing tumor staging and lesion characterization, potentially reducing the need for additional diagnostic studies and leading to more accurate interpretations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indeterminate Findings on Oncologic PET/CT: What Difference Does PET/MRI Make? Fraum, TJ., Fowler, KJ., McConathy, J., et al.[2020]

In a study of 20 pulmonary arterial hypertension (PAH) patients who underwent PET/MRI scans over 24 months, therapy escalation led to significant improvements in right ventricle (RV) function and reduced glucose uptake, which are linked to better patient prognosis.

Higher baseline glucose uptake in the RV was associated with worse outcomes, indicating that monitoring RV metabolism through PET/MRI could help predict clinical deterioration in PAH patients, suggesting a potential role for this imaging technique in guiding treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of specific pulmonary arterial hypertension therapy on cardiac fluorodeoxyglucose distribution in PET/MRI hybrid imaging-follow-up study. Kazimierczyk, R., Szumowski, P., Nekolla, SG., et al.[2023]

Citations

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

Lung 18F-Fluorodeoxyglucose Positron Emission ... We hypothesized that increased lung FDG-PET reflects enhanced glycolysis in vascular cells and is reversible in response to effective therapies.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1936878X21004885

Pulmonary Artery 18F-Fluorodeoxyglucose Uptake by PET ... We demonstrate that 18 F-FDG uptake by PET/CMR in the PA is associated with PH and that its intensity correlates with PA pressure.

3. 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.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/pul2.12025

Development of a PET/MRI exercise stress test for ... Development of a PET/MRI exercise stress test for determining cardiac glucose dependence in pulmonary arterial hypertension

5. journals.lww.com journals.lww.com/md-journal/fulltext/2023/04210/diagnostic_significance_of_mri_versus_ct_using.12.aspx

Diagnostic significance of MRI versus CT using identical PET In this retrospective study we compared magnet resonance imaging (MRI) and computed tomography (CT)

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12492524/

An innovative hybrid imaging protocol for whole-body 18F- ... This study demonstrates the feasibility of a novel, time-efficient, integrated 18F-FDG PET/MRI protocol combining oncologic staging with ...

7. ahajournals.org ahajournals.org/doi/pdf/10.1161/CIRCIMAGING.110.963207

PET Imaging May Provide a Novel Biomarker and ... Conclusions—PET scanning with 13N-NH3 and 18F-fluorodeoxyglucose is a feasible modality for quantifying RV blood flow and metabolism in patients with idiopathic ...

8. publications.ersnet.org publications.ersnet.org/content/erj/64/4/2401128

Emerging multimodality imaging techniques for the pulmonary ... In this review, we explore advances in imaging of the pulmonary vasculature and their potential clinical translation.

9. aetna.com aetna.com/cpb/medical/data/1_99/0071.html

Positron Emission Tomography (PET) - Medical Clinical ... Aetna considers positron emission tomography (PET) medically necessary for the following cardiac indications: Evaluation of Coronary Artery Disease.

10. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/23/NCT03245723/Prot_SAP_003.pdf

Cardiac function and metabolism in young adults born ... The purpose of this study is to determine the effects of premature birth on cardiac function, cardiac metabolism, and oxidative stress in a ...