40 Participants Needed

PET/MR Imaging for Pulmonary Hypertension

AH
PV
Overseen ByPatrick Veit-Haibach, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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.12345

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.678910

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.1112131415

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

PV

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.
See 1 more

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
1Treatment groups
Experimental Treatment
Group I: One arm / exploratory studyExperimental Treatment1 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:

πŸ‡ͺπŸ‡Ί
Approved in European Union as PET/MRI with 18F-FDG for:
  • Diagnostic imaging for various cancers and conditions, including pulmonary hypertension
πŸ‡ΊπŸ‡Έ
Approved in United States as PET/MRI with 18F-FDG for:
  • Diagnostic imaging for various cancers and conditions, including pulmonary hypertension
πŸ‡¨πŸ‡¦
Approved in Canada as PET/MRI with 18F-FDG for:
  • Diagnostic imaging for various cancers and conditions, including pulmonary hypertension
πŸ‡―πŸ‡΅
Approved in Japan as PET/MRI with 18F-FDG for:
  • Diagnostic imaging for various cancers and conditions, including pulmonary hypertension

Find a Clinic Near You

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

References

Integrated 18F-FDG PET/MR imaging in the assessment of cardiac masses: a pilot study. [2022]
Clinical use of cardiac PET/MRI: current state-of-the-art and potential future applications. [2018]
Indeterminate Findings on Oncologic PET/CT: What Difference Does PET/MRI Make? [2020]
Integrated whole body MR/PET: where are we? [2018]
[A review on cardiac positron emission tomography/magnetic resonance imaging in diagnosis of cardivascular diseases]. [2023]
The impact of specific pulmonary arterial hypertension therapy on cardiac fluorodeoxyglucose distribution in PET/MRI hybrid imaging-follow-up study. [2023]
Paradoxical interventricular septal motion as a major determinant of late gadolinium enhancement in ventricular insertion points in pulmonary hypertension. [2021]
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]
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 Statespubmed.ncbi.nlm.nih.gov
Thoracic [18F]fluorodeoxyglucose uptake measured by positron emission tomography/computed tomography in pulmonary hypertension. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Multiparametric Magnetic Resonance Imaging in the Assessment of Pulmonary Hypertension: Initial Experience of a One-Stop Study. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Integrated Cardiopulmonary MRI Assessment of Pulmonary Hypertension. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Cardiac Magnetic Resonance in Pulmonary Hypertension-an Update. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
Imaging in the evaluation of pulmonary artery hemodynamics and right ventricular structure and function. [2016]
15.United Statespubmed.ncbi.nlm.nih.gov
Cardiac MRI in Pulmonary Hypertension: From Magnet to Bedside. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceΒ·Privacy PolicyΒ·CookiesΒ·Security