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| ID | Type | Description | Link |
|---|---|---|---|
| JT 20888 | Other Identifier | JeffTrial Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (sarcoidosis FDG PET-CT) | Experimental | Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludeoxyglucose F-18 | Other | Given FDG |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean standardized uptake value (SUV) changes in the heart | Measured by sarcoidosis fludeoxyglucose F-18 (FDG) positron emission tomography (PET)-computed tomography (CT) scans. | Up to 30 months after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Ability of pre- to post-radiotherapy SUV changes in the heart | Measured by sarcoidosis FDG PET-CT scans. | Up to 30 months after radiotherapy |
| Overall survival | Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yevgeniy Vinogradskiy, MD | Contact | 215-955-3605 | yevgeniy.vinogradskiy@jefferson.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yevgeniy Vinogradskiy | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| Positron Emission Tomography | Procedure | Undergo PET-CT |
|
|
| Computed Tomography | Procedure | Undergo PET-CT |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Up to 30 months after radiotherapy |
| Cardiac toxicity | Assessed using >= grade 2 and >= grade cardiac events using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | Up to 30 months after radiotherapy |
| Cardiac toxicity judged to be secondary to radiotherapy by cardiologist and radiation oncologist | Judged to be secondary to radiotherapy by cardiologist and radiation oncologist | Up to 30 months after radiotherapy |
| Cardiac related death | Death | Up to 30 months after radiotherapy |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| D009682 | Magnetic Resonance Spectroscopy |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
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