PET/CT Imaging for Heart Function in Lung Cancer

Overseen By Yevgeniy Vinogradskiy, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Contraindication for FDG PET-CT, others

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

Compensation: Varies

Number of Visits: 15

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses PET/CT scans to assess how radiation therapy affects heart function in individuals with lung or esophageal cancer. Radiation treatment for these cancers sometimes exposes the heart, and the impact on heart function remains unclear. The study aims to help doctors detect any heart changes before, during, and after radiation treatment. Individuals with lung or esophageal cancer scheduled for radiation therapy may be suitable for this trial, particularly if their heart might receive some radiation exposure. As an unphased trial, this study offers a unique opportunity to contribute to understanding heart health during cancer treatment.

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 trial coordinators or your doctor.

What prior data suggests that PET/CT imaging is safe for evaluating heart function in cancer patients?

Research has shown that FDG PET-CT scans, commonly used for imaging, are generally well-tolerated and often evaluate various conditions, including cancer. Studies have found FDG PET-CT to be more accurate than some other imaging methods for assessing lung cancer. However, PET scans involve radiation, and sometimes the risks may outweigh the benefits, especially for screening.

In this trial, PET-CT scans monitor heart changes caused by radiation therapy in patients with lung or esophageal cancer. While the scans are safe, they do expose patients to some radiation. It's important to weigh this exposure against the potential benefits of early detection of heart changes.

Overall, the scans are considered safe when used correctly, and doctors will closely monitor for any side effects. Prospective participants should discuss any concerns with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using PET/CT imaging for heart function in lung cancer patients because it offers a more detailed and dynamic view of the heart compared to traditional imaging methods. Unlike standard care options that might rely on separate scans, this method combines positron emission tomography (PET) and computed tomography (CT) to provide both metabolic and anatomical information in a single session. This integrated approach helps in assessing how well the heart is functioning before, during, and after radiotherapy, potentially leading to more personalized and effective treatment plans for patients.

What evidence suggests that PET/CT imaging is effective for evaluating heart function in lung cancer patients?

Research has shown that FDG PET-CT scans effectively detect changes in heart function, particularly before and after radiation therapy. In this trial, participants will undergo sarcoidosis FDG PET-CT of the heart before, during, and after radiotherapy. These scans identify changes in heart tissue that might result from radiation. Studies have demonstrated that FDG PET-CT can predict heart health by analyzing images taken before treatment begins. This imaging method can also distinguish between healthy and damaged heart tissue. Overall, FDG PET-CT is valuable for monitoring heart health during cancer treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Yevgeniy Vinogradskiy, MD

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

This trial is for adults with pathologically confirmed lung cancer who are about to undergo radiation therapy and have a life expectancy of at least 3 months. They must consent to the study's procedures, be available throughout, and receive a heart dose of radiation estimated at 5 Gy or more. It excludes those on palliative radiation doses or with contraindications for FDG PET-CT scans.

Inclusion Criteria

Provide signed and dated informed consent form

Life expectancy >= 3 months as assessed by Radiation Oncologist

My heart is expected to receive a radiation dose of 5 Gy or more.

Exclusion Criteria

Contraindication for FDG PET-CT scans as assessed by the radiation oncologist or nuclear medicine radiologist

I received a specific low-dose radiation treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Patients undergo radiation therapy as part of their cancer treatment

Varies based on individual treatment plans

Multiple visits for radiation sessions

Imaging

Patients undergo sarcoidosis FDG PET-CT of the heart before, during, and after radiotherapy to monitor changes

Concurrent with radiation therapy

3 visits for imaging (before, during, after radiotherapy)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Follow-up visits at 12 and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Computed Tomography
• Positron Emission Tomography

Trial Overview The EUCLID Trial is testing the use of PET/CT imaging to detect potential cardiac damage from radiation treatment in lung cancer patients. The goal is to monitor heart function before, during, and after radiotherapy using this imaging technique which can highlight inflammation and tissue viability.

How Is the Trial Designed?

Group I: Diagnostic (sarcoidosis FDG PET-CT) Experimental Treatment 4 Interventions

Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Published Research Related to This Trial

In a study of 22 patients with esophageal cancer, radiation doses of 20 Gy or higher significantly reduced myocardial blood flow (MBF) in the heart's left ventricle three months after radiation therapy, indicating potential cardiac risks associated with higher radiation exposure.

The findings suggest that monitoring and managing radiation doses during treatment could be crucial in preventing late adverse cardiac events in patients undergoing radiation therapy for thoracic malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results of reduced myocardial blood flow in the subacute phase after radiation therapy for thoracic esophageal cancer: A quantitative analysis with stress dynamic myocardial computed tomography perfusion imaging. Takada, A., Ichikawa, Y., Nakamura, S., et al.[2023]

A study involving 701 patients with locally advanced non-small cell lung cancer (LA-NSCLC) developed a model to predict major adverse cardiac events (MACE) after radiotherapy, identifying pre-existing coronary heart disease (CHD), hypertension, and the dose to the left anterior descending (LAD) coronary artery as key risk factors.

The prediction model, named CHyLL, demonstrated good accuracy in estimating MACE risk, with a c-index of 0.76 in a test cohort, and it can help determine safe radiation dose limits for patients based on their individual cardiac risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Major adverse cardiac event risk prediction model incorporating baseline Cardiac disease, Hypertension, and Logarithmic Left anterior descending coronary artery radiation dose in lung cancer (CHyLL). Tjong, MC., Bitterman, DS., Brantley, K., et al.[2022]

In a study of 143 lung cancer patients, PET/CT scans effectively detected nodal involvement in 60% of cases, with a high specificity of 99.8% and sensitivity of 86.4% when using SUVmax cut-off values of 4.4 for hilar nodes and 4.0 for mediastinal nodes.

The scans also revealed that distant metastases were present in 46.2% of patients, predominantly affecting bones, adrenal glands, and the liver, highlighting the importance of PET/CT in comprehensive cancer staging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Positron emission tomography/computed tomography for lung cancer staging]. Ladrón de Guevara H, D., Furnaro L, F., Yévenes A, S., et al.[2016]

Whole-body PET using [18F]-FDG is crucial for diagnosing and managing lung cancer, as it helps distinguish between benign and malignant tissues based on FDG accumulation in cancer cells.

Combining PET with CT imaging significantly enhances the accuracy of locating cancerous tissues, making PET/CT superior to either method alone for evaluating pulmonary nodules and staging non-small-cell lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnosis of lung cancer. Role of PET/CT fusion scan in lung cancer]. Melloni, B., Gazaille, V., Bertin, F., et al.[2007]

In a study of 151 patients followed for an average of 3.2 years, a reduced early post-stress left ventricular ejection fraction reserve (EFR) was significantly associated with major cardiac adverse events (MACE), indicating its potential as a predictive marker for cardiac risk.

Patients with an early EFR of less than 0% or a change in end-systolic volume (∆ESV) of 5 ml or more experienced decreased event-free survival, highlighting the importance of early stress imaging in assessing cardiac health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic value of early left ventricular ejection fraction reserve during regadenoson stress solid-state SPECT-MPI. Otaki, Y., Fish, MB., Miller, RJH., et al.[2022]

In a study of 127 patients with stage III non-small-cell lung cancer treated with high-dose radiotherapy, 23% experienced cardiac events, indicating that cardiac injury is a significant concern following treatment.

Higher doses of radiation to the heart were linked to an increased risk of these events, with a notable increase in risk for doses above 20 Gy, suggesting that minimizing heart exposure during radiotherapy is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Toxicity After Radiotherapy for Stage III Non-Small-Cell Lung Cancer: Pooled Analysis of Dose-Escalation Trials Delivering 70 to 90 Gy. Wang, K., Eblan, MJ., Deal, AM., et al.[2022]

In a study comparing cardiac PET to SPECT imaging in 14,594 patients, the PET-based program significantly improved the identification of high-grade obstructive coronary artery disease (CAD), leading to more patients undergoing necessary revascularization procedures.

Despite the increased identification and treatment of CAD with PET, there was no significant difference in the rate of major adverse cardiovascular events (MACE) after one year between the two imaging modalities, indicating that while PET is more effective in diagnosis, it does not necessarily lead to better long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a cardiac PET stress program: comparison of outcomes to the preceding SPECT era. Knight, S., Min, DB., Le, VT., et al.[2019]

Positron emission tomography (PET) using F-18 fluoro-deoxyglucose (FDG) is effective in detecting active lung tumors that may not be visible on CT scans or chest X-rays, aiding in early diagnosis.

In a study of 135 FDG-PET scans conducted over nearly two years, PET was found to be valuable for staging lung cancer before and after treatments like surgery, chemotherapy, or radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Contribution of PET using FDG in the diagnosis of lung cancer--first results]. Rubinstein, R., Breuer, R., Chisin, R.[2016]

PET-CT imaging is a valuable tool in lung cancer management, aiding in the evaluation of pulmonary nodules, initial staging, restaging after treatment, and planning for radiation therapy.

The integration of anatomical and metabolic data from PET-CT scans allows for a comprehensive assessment, enhancing the accuracy of diagnosis and treatment planning for lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of positron emission tomography-computed tomography in pulmonary neoplasms. Shreve, P., Faasse, T.[2016]

PET/CT scanning using 18F-2-deoxy-D-glucose is effective in detecting nodal and extrathoracic metastases in lung cancer patients, enhancing conventional imaging methods.

The use of PET scanning is being explored for its potential to assess prognosis and therapeutic response, which could significantly influence the management of lung cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positron emission tomography/computed tomography in lung cancer staging, prognosis, and assessment of therapeutic response. Truong, MT., Viswanathan, C., Erasmus, JJ.[2022]

The use of PET-CT in veterans diagnosed with non-small cell lung cancer (NSCLC) significantly increased from 2000 to 2013, and this increase was associated with a decrease in 5-year mortality rates, suggesting that PET-CT may improve patient outcomes.

Veterans who received PET-CT before diagnosis were more likely to receive stage-appropriate treatment, which correlated with a 22% reduction in both all-cause and NSCLC-specific mortality, highlighting the importance of early imaging in managing lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Receipt of Positron Emission Tomography-Computed Tomography With Non-Small Cell Lung Cancer Mortality in the Veterans Affairs Health Care System. Vella, M., Meyer, CS., Zhang, N., et al.[2020]

FDG-PET imaging is a valuable tool for diagnosing and staging lung cancer, helping to predict how well patients will respond to therapy and assess the aggressiveness of tumors.

Advancements in PET technology and the development of more specific radiopharmaceuticals are expected to enhance the management and treatment of lung cancer patients in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of FDG-PET scanning in lung cancer]. Sönmezoğlu, K.[2016]

FDG-PET/CT imaging has significantly improved the diagnosis and management of lung cancer, aiding in the development of therapeutic biomarkers and predicting patient responses and long-term survival.

The review highlights ongoing advancements in novel tracers and optimized procedures for PET/CT, suggesting a promising future for enhancing the effectiveness of lung cancer imaging and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress and future prospective of FDG-PET/CT imaging combined with optimized procedures in lung cancer: toward precision medicine. Guo, H., Xu, K., Duan, G., et al.[2022]

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