Diffusion-Weighted Magnetic Resonance Imaging
Primary Purpose
Hepatocellular Carcinoma, Spine Metastasis
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
External beam radiation therapy
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatocellular Carcinoma
Eligibility Criteria
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)
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EBRT
Arm Description
Outcomes
Primary Outcome Measures
oral morphine equivalent doseresponse criteria
Degree of pain will be assessed via Visual Analog Scale for Pain (VAS).
Secondary Outcome Measures
Modified Response Evaluation Criteria in Solid Tumor
Time to local tumor progression
Overall survival
Quality of Life
Quality of life will be assessed via European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaire (QLQ)-C15-PAL.
Full Information
NCT ID
NCT02242786
First Posted
August 22, 2014
Last Updated
November 6, 2014
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02242786
Brief Title
Diffusion-Weighted Magnetic Resonance Imaging
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Spine Metastasis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EBRT
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
External beam radiation therapy
Primary Outcome Measure Information:
Title
oral morphine equivalent doseresponse criteria
Description
Degree of pain will be assessed via Visual Analog Scale for Pain (VAS).
Time Frame
3 months after RT completion
Secondary Outcome Measure Information:
Title
Modified Response Evaluation Criteria in Solid Tumor
Time Frame
3 months after RT completion
Title
Time to local tumor progression
Time Frame
From RT start to the date up to 24 weeks
Title
Overall survival
Time Frame
From RT start to the date up to 24 weeks
Title
Quality of Life
Description
Quality of life will be assessed via European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaire (QLQ)-C15-PAL.
Time Frame
3 months after RT completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jong Won Kwon, MD, PhD
Phone
82-2-3410-2548
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Won Park, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong Won Park, M.D., Ph.D.
Phone
82-2-3410-2548
First Name & Middle Initial & Last Name & Degree
Hee Chul Park, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Jeong Il Yu, MD
12. IPD Sharing Statement
Learn more about this trial
Diffusion-Weighted Magnetic Resonance Imaging
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