Esophageal Cancer Clinical Trial
PET/CT Imaging to Evaluate Cardiac Radiation Damage in Patients With Lung or Esophageal Cancer, EUCLID Trial
Summary
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.
Full Description
PRIMARY OBJECTIVE:
I. To characterize radiation-related functional imaging changes in the heart using sarcoidosis fludeoxyglucose F-18 (FDG) PET-CT imaging.
SECONDARY OBJECTIVES:
I. 1. To evaluate the ability of imaging changes in the heart to predict for overall survival (OS).
II. To evaluate the ability of imaging changes in the heart to predict for cardiac toxicity.
III. To evaluate the ability of imaging changes in the heart to predict for cardiac related death.
EXPLORATORY OBJECTIVES:
I. To evaluate radiation treatment planning strategies to reduce risk of cardiotoxicity.
II. To determine the correlation between sarcoidosis FDG PET-CT scans and oncologic FDG PET-CT scans.
OUTLINE:
Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy.
After completion of study treatment, patients are followed up at 12 and 24 months.
Eligibility Criteria
Inclusion Criteria:
Provide signed and dated informed consent form
Willing to comply with all study procedures and be available for the duration of the study
Male or female, aged >= 18
Life expectancy >= 3 months as assessed by Radiation Oncologist
Mean heart dose estimated by Radiation Oncologist to be >= 5 Gy (physics dose or biologically equivalent dose)
Pathologically proven (either histologic or cytologic) proven lung cancer or esophageal cancer
Planned radiation treatment course for management of lung or esophageal cancer * Both standard and hypofractionation schedules are permitted
Exclusion Criteria:
Contraindication for FDG PET-CT scans as assessed by the radiation oncologist or nuclear medicine radiologist
Palliative radiation doses defined as 20 Gy in 5 fractions
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