PET/CT Imaging to Evaluate Cardiac Radiation Damage in Patients With Lung Cancer, EUCLID Trial

Study Overview
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Brief Summary
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This clinical trial examines positron emission tomography (PET)/computed tomography (CT) in evaluating cardiac radiation damage in patients with lung cancer. As part of the treatment for lung 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.

Detailed Description
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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.

Official Title
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PET fUnCtionaL Imaging to Evaluate Cardiac Radiation Damage (EUCLID)

Conditions
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Lung Carcinoma

Intervention / Treatment
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* Other: Fludeoxyglucose F-18
* Procedure: Positron Emission Tomography
* Procedure: Computed Tomography
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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 Pathologically proven (either histologic or cytologic) proven lung cancer Planned radiation treatment course for management of lung cancer * Both standard and hypofractionated 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 30 Gy in 10 fractions or 20 Gy in 5 fractions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (sarcoidosis FDG PET-CT)<br>Patients undergo sarcoidosis FDG PET-CT of the heart before, during and, after radiotherapy. | Other: Fludeoxyglucose F-18<br>* Given FDG<br>* Other names: Fluorodeoxyglucose F18;Procedure: Positron Emission Tomography<br>* Undergo PET-CT<br>* Other names: PT;Procedure: Computed Tomography<br>* Undergo PET-CT<br>* Other names: tomography;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |