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

Trial Summary

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 data supports the effectiveness of the treatment PET/MR with 18F-FDG for pulmonary hypertension?

PET/MRI with 18F-FDG is a promising tool for diagnosing and monitoring heart-related conditions, as it combines detailed images of the body's structure with information about how tissues are functioning. This approach has shown potential in assessing heart diseases and could help in understanding and managing pulmonary hypertension by providing comprehensive insights into heart and lung function. ^{1 2 3 4 5}

Is PET/MR Imaging with 18F-FDG safe for humans?

The research articles provided do not contain specific safety data for PET/MR Imaging with 18F-FDG, but this imaging technique is commonly used in medical settings and is generally considered safe for humans. ^{6 7 8 9 10}

How is the PET/MR with 18F-FDG treatment different from other treatments for pulmonary hypertension?

The PET/MR with 18F-FDG treatment is unique because it combines advanced imaging techniques to provide a comprehensive view of both the heart and lungs in a single exam, helping to diagnose and assess pulmonary hypertension more accurately than traditional methods. ^{11 12 13 14 15}

What is the purpose of this trial?

Radiotherapy (RT) is a well-known and established therapy or adjuvant therapy for the treatment of thoracic cancer It uses a high energy radiation from x-rays, gamma rays and other charged particles that assist in damaging the cancer DNA. PET/MR as imaging biomarkers for cardiopulmonary dysfunction with a focus on Pulmonary hypertension (PH). Despite the measures taken to reduce the total radiation dose and to limit the radiation to normal tissues, there is evidence of transient or permanent radiotherapy induced myocardial and pulmonary dysfunction leading to PH in patients who receive radiotherapy above a certain threshold of received dose. To be able to Demonstrate correlation of combined PET/MR and plasma metabolomics markers in patients at risk of developing cardiopulmonary disfunction after RT.

Research Team

Patrick Veit-Haibach, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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 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]

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]

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]

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]

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]

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]

References

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

Integrated 18F-FDG PET/MR imaging in the assessment of cardiac masses: a pilot study. [2022]

2. Japan pubmed.ncbi.nlm.nih.gov

Clinical use of cardiac PET/MRI: current state-of-the-art and potential future applications. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Indeterminate Findings on Oncologic PET/CT: What Difference Does PET/MRI Make? [2020]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Integrated whole body MR/PET: where are we? [2018]

5. China pubmed.ncbi.nlm.nih.gov

[A review on cardiac positron emission tomography/magnetic resonance imaging in diagnosis of cardivascular diseases]. [2023]

6. Germany 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. [2023]

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

Paradoxical interventricular septal motion as a major determinant of late gadolinium enhancement in ventricular insertion points in pulmonary hypertension. [2021]

8. United States 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. [2016]

9. 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]

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

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

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

Multiparametric Magnetic Resonance Imaging in the Assessment of Pulmonary Hypertension: Initial Experience of a One-Stop Study. [2019]

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

Integrated Cardiopulmonary MRI Assessment of Pulmonary Hypertension. [2023]

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

Cardiac Magnetic Resonance in Pulmonary Hypertension-an Update. [2022]

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

Imaging in the evaluation of pulmonary artery hemodynamics and right ventricular structure and function. [2016]

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

Cardiac MRI in Pulmonary Hypertension: From Magnet to Bedside. [2021]