Hepatocellular Carcinoma, Spine Metastasis
Conditions
Brief summary
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.
Interventions
RADIATIONExternal beam radiation therapy
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| oral morphine equivalent doseresponse criteria | 3 months after RT completion | Degree of pain will be assessed via Visual Analog Scale for Pain (VAS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 3 months after RT completion | Quality of life will be assessed via European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaire (QLQ)-C15-PAL. |
Countries
South Korea
Contacts
Primary ContactJong Won Kwon, MD, PhD
Outcome results
None listed