Diffusion-Weighted Magnetic Resonance Imaging

Phase 2

• Conditions: Spine Metastasis; Hepatocellular Carcinoma
• Interventions: Radiation: External beam radiation therapy

• Registration Number: NCT02242786
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-22
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-17
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-06
• Last Update Posted: 2014-11-07
• Primary Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 17

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EBRT	External beam radiation therapy	-

Primary Outcome Measures

Name	Time	Method
oral morphine equivalent doseresponse criteria	3 months after RT completion	Degree of pain will be assessed via Visual Analog Scale for Pain (VAS).

Secondary Outcome Measures

Name	Time	Method
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.
Overall survival	From RT start to the date up to 24 weeks
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of