Early Imaging Biomarkers in NSCLC

Study Overview
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Brief Summary
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The purpose of this study is to investigate if cardiac MRI, blood biomarkers, and lung CT scans can detect early changes to the associated with radiation therapy in patients receiving radiation treatment for thoracic cancer.

Detailed Description
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This study seeks to investigate the utility of novel imaging biomarkers, namely whole lung volumetric CT scans and cardiac MRI, to non-invasively identify early pathologic changes in pulmonary and cardiac function resulting from thoracic radiation. The ability to identify these changes during the course of treatment offers a powerful tool to optimize radiation dose distributions within uninvolved normal tissue by adapting treatment to the individual patient response. In addition it may lead to other therapeutic interventions designed to reduce long term cardiopulmonary toxicity. The cardiac MRI will be performed using Aminophylline, Gadopentetate Dimeglumine and Regadenoson. These are not FDA approved for this purpose, but are being used off label and are IND exempt. Additionally, patients will be consented with an optional choice to retain research blood samples for 15 years after the completion of the study. This will allow cutting edge analysis for biomarkers that may be discovered in the future.

Official Title
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Early Imaging Biomarkers to Predict Radiation-Induced Cardiopulmonary Toxicity in Patients With Thoracic Malignancies

Conditions
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Thoracic Cancer

Intervention / Treatment
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* Other: Imaging Biomarkers
* Other: Pulmonary
* Other: Imaging
* Other: Specimen Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving once daily fractionated intrathoracic radiation therapy for: Stage IIA-IIIB non-small cell lung cancer Limited stage small cell lung cancer Stage I-III esophageal cancer (neoadjuvant or definitive) Patients must be 18 years of age or older Must not be claustrophobic Must have adequate kidney function Exclusion Criteria: Patients with small cell lung cancer receiving twice daily (b.i.d.) radiation Patients with esophageal cancer receiving trastuzamab Pregnancy or lactation Claustrophobia Inability to lie flat for 60-90 minutes Renal dysfunction with eGFR <60 mL/min/1.73 m2 Allergy to gadolinium containing contrast media Implanted devices, metallic hazards or other conditions presenting a contraindication to 3Tesla cardiac MRI

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung or Esophageal Patients<br>Patients with lung or esophageal cancer undergoing conventionally-fractionated radiation therapy. Interventions to be administered include: Imaging Biomarkers using Volumetric CT Scans, Pulmonary using Pulmonary Function Test & 6Minute Hall Walk, Imaging using Cardiac MRI, Specimen Collection using Blood Draws. | Other: Imaging Biomarkers<br>* Whole lung volumetric CT scans<br>Other: Pulmonary<br>* Pulmonary Function Tests & 6 minute hall walk<br>Other: Imaging<br>* Cardiac MRI<br>Other: Specimen Collection<br>* Blood draw<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Lung Function | To characterize longitudinal changes in lung function using a voxel-wise image analysis technique of whole-lung CT scans in patients undergoing intrathoracic radiation therapy. | 1 Year post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Myocardial Tissue | To assess longitudinal changes in myocardial tissue and coronary vasculature physiology, using cardiac MR in patients undergoing intrathoracic radiation therapy. | 1 Year post treatment | 
| Change from Baseline in Myocardial Tissue | To assess longitudinal changes in myocardial tissue and coronary vasculature physiology, including microvascular dysfunction, using cardiac MR in patients undergoing intrathoracic radiation therapy. | 1 Year post treatment | 
| Change from Baseline in Myocardial Tissue | To assess longitudinal changes in myocardial tissue and coronary vasculature physiology, including diffuse fibrosis, using cardiac MR in patients undergoing intrathoracic radiation therapy. | 1 Year post treatment | 
| Radiation Predictors from Baseline in Cardiopulmonary Changes | To explore radiation dosimetric predictors of CT- and MR-detectible cardiopulmonary changes. | 1 Year post treatment |