Diffusion-Weighted Magnetic Resonance Imaging

Study Overview
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Brief Summary
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Recently, diffusion-weighted (DW) MR imaging has widened its application on various oncologic applications. Especially, it is expected the DW MRI could provide valuable information about early response evaluation after treatment using rapid apparent diffusion coefficient (ADC) value change. It has demonstrated potential usefulness in response evaluation in the liver tumors after treatments such as transarterial chemoembolization (TACE) and radiation therapy (RT). Furthermore, it is a functional imaging technique that does not require a contrast agent, it can be safely used in patients with renal insufficiency or other medical contraindications for contrast agents. The optimal assessment of early response of RT could provide one of the most important information to prescribe patient and cancer specific RT dose. It might be also important in palliative RT of HCC bone metastasis which is related with painful aggressive mass formation. This study is performed to evaluate the usefulness of DW MRI in early response evaluation after RT for HCC bone metastasis.

Official Title
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Response Assessment for External Beam Radiation Therapy in Spinal Metastasis of Hepatocellular Carcinoma (HCC): Usefulness of Diffusion-Weighted Magnetic Resonance (MR) Imaging as A Functional Imaging

Conditions
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Hepatocellular Carcinoma, Spine Metastasis

Intervention / Treatment
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* Radiation: External beam radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hepatocellular carcinoma Spine metastasis Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3 20 or older age informed consent consent to birth control during 6 months after treatment Exclusion Criteria: less than 12 weeks of expected survival indication of emergency operation uncontrolled ascites or encephalopathy previous RT field lesion (within in 1 month)

Ages Eligible for Study
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Minimum Age: 20 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: EBRT<br> | Radiation: External beam radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral morphine equivalent doseresponse criteria | Degree of pain will be assessed via Visual Analog Scale for Pain (VAS). | 3 months after RT completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Response Evaluation Criteria in Solid Tumor |  | 3 months after RT completion | 
| Time to local tumor progression |  | From RT start to the date up to 24 weeks | 
| Overall survival |  | From RT start to the date up to 24 weeks | 
| Quality of Life | Quality of life will be assessed via European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaire (QLQ)-C15-PAL. | 3 months after RT completion |