Dynamic Contrast Enhanced Computed Tomography to Assess Radiation Therapy in Liver Cancer Patients

Study Overview
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Brief Summary
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This is a pilot study that uses a standard of care technique, Stereotactic Body Radiation Therapy (SBRT), in combination with Dynamic Contrast Enhanced Computed Tomography (DCE-CT) to determine if perfusion changes from SBRT of liver cancer may be used for outcome assessment and prediction of prognosis.

Detailed Description
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Patients will undergo standard of care SBRT while also receiving DCE-CT, also known as perfusion CT, pre-treatment, 6 hours post-treatment and 6 weeks post-treatment.

Official Title
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Pilot Study of Dynamic Contrast Enhanced Computed Tomography (DCE-CT) Imaging for the Assessment of Radiation Therapy Outcome for Liver Cancer Patients

Conditions
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Liver Cancer

Intervention / Treatment
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* Diagnostic Test: Dynamic Contrast Enhanced Computed Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision to sign and date the consent form Stated willingness to comply with all study procedures and be available for the duration of the study Be a Male or Female aged 18-100 Diagnosed with Liver HCC or metastases Must be receiving or will plan to receive SBRT for Liver HCC or metastases Exclusion Criteria: Allergy to iodine contrast CT with contrast not offered as a Standard of Care Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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
Interventional Model Description: Each patient will receive the standard of care, with the intervention, DCE-CT perfusion, occurring pre-treatment and post-treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic Contrast Enhanced Computed Tomography<br>DCE-CT, also known as perfusion CT, is a functional imaging modality that uses repeated computed tomography imaging after injection of an iodine based contrast agent. | Diagnostic Test: Dynamic Contrast Enhanced Computed Tomography<br>* Patients will receive DCE-CT prior to the start of standard of care, Stereotactic Body Radiation Therapy (SBRT), as well as 6 hours post administration of SBRT and 6 weeks post administration of SBRT.<br>* Other names: Perfusion CT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DCE-CT Perfusion Metrics: K-Trans | Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through K-Trans (extraction-flow product) as shown through DCE-CT imaging. | Baseline to end of follow-up, up to 12 weeks | 
| DCE-CT Perfusion Metrics: Blood Volume | Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through blood volume as shown through DCE-CT imaging. | Baseline to end of follow-up, up to 12 weeks | 
| DCE-CT Perfusion Metrics: Blood Flow | Determine the association between the delivered radiation therapy dose distribution and the change in perfusion measurement through blood flow as shown through DCE-CT imaging. | Baseline to end of follow-up, up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Between Patient Demographics and K-Trans: Age | Stratify K-Trans results by age to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months | 
| Correlation Between Patient Demographics and K-Trans: Sex | Stratify K-Trans results by sex to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months | 
| Correlation Between Patient Demographics and K-Trans: Race | Stratify K-Trans results by race to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months | 
| Correlation Between Patient Demographics and K-Trans: Clinical Stage of Disease | Stratify K-Trans results by clinical stage at diagnosis to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months | 
| Correlation Between Patient Demographics and Blood Volume: Age | Stratify blood volume results age to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months | 
| Correlation Between Patient Demographics and Blood Volume: Sex | Stratify blood volume results sex to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months | 
| Correlation Between Patient Demographics and Blood Volume: Race | Stratify blood volume results race to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months | 
| Correlation Between Patient Demographics and Blood Volume: Clinical Stage of Disease | Stratify blood volume results by clinical stage at diagnosis to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months | 
| Correlation Between Patient Demographics and Blood Flow: Age | Stratify blood flow results age to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months | 
| Correlation Between Patient Demographics and Blood Flow: Sex | Stratify blood flow results sex to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months | 
| Correlation Between Patient Demographics and Blood Flow: Race | Stratify blood flow results race to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months | 
| Correlation Between Patient Demographics and Blood Flow: Clinical Stage of Disease | Stratify blood flow results by clinical stage at diagnosis to determine correlation of DCE-CT imaging results compared to patient demographics | Post follow-up to end of study, up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation, Metastases, Dynamic Contrast Enhanced Computed Tomography, Pilot