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

Trial Summary

What is the purpose of this trial?

This clinical trial examines positron emission tomography (PET)/computed tomography (CT) in evaluating cardiac radiation damage in patients with lung or esophageal cancer. As part of the treatment for lung or esophageal cancer, patients will undergo radiation therapy. Sometimes, during this treatment, the heart is also subjected to some radiation which could affect its function, either increasing or decreasing the function. It is not known the consequences of this change nor is it known if doctors can detect the changes associated with the radiation. Sarcoidosis FDG positron emission tomography (PET)-computed tomography (CT) scans are a common way to image cardiac inflammation and myocardial viability. This study may help doctors image the heart before, during and after radiotherapy to monitor any changes.

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 data supports the effectiveness of PET/CT imaging for heart function in lung cancer treatment?

PET/CT imaging, which combines two types of scans, has been shown to be very useful in diagnosing and staging lung cancer, predicting how well a treatment might work, and assessing the aggressiveness of tumors. This imaging technique helps in early diagnosis and can guide treatment decisions, potentially improving patient outcomes. ^{1 2 3 4 5}

Is PET/CT imaging safe for humans?

PET/CT imaging is generally considered safe for humans, as it is a widely used diagnostic tool. However, like any medical procedure, it may have some risks, such as exposure to radiation, but these are typically low and managed carefully in clinical settings. ^{6 7 8 9 10}

How does PET/CT imaging differ from other treatments for lung cancer?

PET/CT imaging is unique because it combines two types of scans to provide both detailed pictures and information about the activity of cancer cells, helping in the diagnosis, staging, and management of lung cancer more effectively than traditional imaging methods. ^{1 5 11 12 13}

Research Team

Yevgeniy Vinogradskiy, MD

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

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

I am 18 years old or older.

Provide signed and dated informed consent form

Life expectancy >= 3 months as assessed by Radiation Oncologist

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Progress and future prospective of FDG-PET/CT imaging combined with optimized procedures in lung cancer: toward precision medicine. [2022]

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

Positron emission tomography/computed tomography in lung cancer staging, prognosis, and assessment of therapeutic response. [2022]

3. United States 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. [2020]

4. Turkey pubmed.ncbi.nlm.nih.gov

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

5. Israel pubmed.ncbi.nlm.nih.gov

[Contribution of PET using FDG in the diagnosis of lung cancer--first results]. [2016]

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

Prognostic value of early left ventricular ejection fraction reserve during regadenoson stress solid-state SPECT-MPI. [2022]

7. Ireland 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. [2023]

8. United States 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. [2022]

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

Implementation of a cardiac PET stress program: comparison of outcomes to the preceding SPECT era. [2019]

10. Ireland 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). [2022]

11. Chile pubmed.ncbi.nlm.nih.gov

[Positron emission tomography/computed tomography for lung cancer staging]. [2016]

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[Diagnosis of lung cancer. Role of PET/CT fusion scan in lung cancer]. [2007]

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

Role of positron emission tomography-computed tomography in pulmonary neoplasms. [2016]