CT Perfusion Imaging in Predicting Treatment Response in Patients With Non-small Cell Lung Cancer or Lung Metastases Treated With Stereotactic Ablative Radiation Therapy

Study Overview
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Brief Summary
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This study assesses computed tomography (CT) perfusion imaging in predicting treatment response in patients with non-small cell lung cancer or tumors that have spread from the primary site (place where it started) to the lungs (metastases) treated with stereotactic ablative radiation therapy. CT perfusion imaging is a special type of CT that uses an injected dye in order to see how blood flow through tissues, including lung tissue. CT perfusion imaging of the lungs may help doctors learn whether perfusion characteristics of lung tumors may be predictive of response to treatment and whether lung perfusion characteristics can be used to follow response to treatment.

Detailed Description
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PRIMARY OBJECTIVES: I. To assess the feasibility of performing computed tomography (CT) perfusion imaging (CT perfusion imaging) at baseline, within 48 hours post-stereotactic ablative radiation therapy (SABR), and at 2-4 months SABR in patients undergoing SABR for treatment of a lung tumor per standard of care. SECONDARY OBJECTIVES: To determine the range (variability) of perfusion parameters at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR To assess the change in perfusion parameters at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR To correlate any change in perfusion parameters with circulating-tumor deoxyribonucleic acid (DNA) levels at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR To correlate perfusion parameters with tumor response 1 year post-SABR OUTLINE: Patients receive an infusion of Isovue-200 and undergo CT perfusion imaging of the lungs at baseline, within 48 hours of first SABR, and at 2-4 months after completion of SABR. Cancer Personalized Profiling by Deep Sequencing (CAPP-Seq) will be conducted evaluate circulating-tumor DNA levels. Perfusion parameters will be correlated with tumor control at 1 year post-SABR, with tumor control defined as no evidence of disease seen at the site of SABR by surveillance imaging at 1 year post-SABR. After completion of treatment, patients are followed up at 2-4 months and then at 1 year.

Official Title
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A Pilot Study of Perfusion CT for Lung Tumors Treated With Stereotactic Ablative Radiation Therapy (SABR)

Conditions
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Malignant Lung Neoplasm, Metastatic Malignant Neoplasm in the Lung, Non-Small Cell Lung Carcinoma, Stage IV Lung Cancer

Intervention / Treatment
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* Device: CAPP-Seq
* Drug: Isovue-200
* Radiation: Computed Tomography Perfusion Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing SABR for the treatment of a lung tumor, inclusive of non-small cell lung cancer or lung metastases Exclusion Criteria: Patients who are pregnant or are trying to become pregnant are excluded from this study Patients with renal failure, defined as glomerular filtration rate (GFR) < 60 at the time of the radiation treatment-planning (RTP) scan, will be excluded

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 (CT perfusion imaging)<br>Patients undergo CT perfusion imaging of the lungs at baseline, within 48 hours of first SABR, and at 2-4 months after completion of SABR. Isovue-200 is used as contrast agent | Device: CAPP-Seq<br>* Cancer Personalized Profiling by Deep Sequencing (CAPP-Seq) is an assay which allows quantitative assessment of the levels of circulating-tumor DNA in the blood sample.<br>* Other names: Cancer Personalized Profiling by Deep Sequencing;Drug: Isovue-200<br>* Contrast agent<br>* Other names: Lopamidol;Radiation: Computed Tomography Perfusion Imaging<br> <br> * Other names: CT Perfusion Imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants able to complete perfusion scan acquisition at the time of treatment-planning |  | Up to approximately 90 seconds | 
| Number of participants able to complete perfusion scan acquisition within 48 hours of SABR |  | Within 48 hours post-SABR | 
| Number of participants able to complete perfusion scan acquisition in follow-up up to 4 months after SABR |  | Up to 4 months post-SABR | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The calculated variance of blood flow such that measurable changes can be identified in future studies |  | Baseline to up to 4 months post-SABR | 
| The calculated variance of blood volume such that measurable changes can be identified in future studies |  | Baseline to up to 4 months post-SABR | 
| The calculated variance of mean transit time such that measurable changes can be identified in future studies |  | Baseline to up to 4 months post-SABR | 
| The calculated variance of permeability such that measurable changes can be identified in future studies |  | Baseline to up to 4 months post-SABR |