Noninvasive Surrogate Marker for Advanced Hepatocellular Carcinoma Response to Concurrent Chemoradiotherapy: MR Perfusion, Contrast Enhanced Ultrasound and Biomarkers
Primary Purpose
Advanced Adult Hepatocellular Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DCE MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Advanced Adult Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients who have advanced hepatocellular carcinoma and plan to undertake concurrent chemoradiotherapy.
- Patients willing to undergo the study procedure
- Patients who are fully informed about the study and have signed the informed consent form
Exclusion Criteria:
- Patients (men or women) under 20 years of age
- Patients who have been received any other treatment including TACE, operation, TACI, systemic chemotherapy, intraarterial chemotherapy, antiangiogenic therapy
- Patients who have hypersensitivity to MR or US contrast agents
- Women who are pregnant, lactating or who are of childbearing potential and have not had a negative pregnancy test at baseline visit
- Patients not eligible to contrast media injection according to product labeling
- Patients with a contraindication for MRI or CT
- Patients with impaired renal function (e.g. acute renal failure) or patients on dialysis
Sites / Locations
- Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CCRTx
Arm Description
consecutive patients who plan to undertake CCRTx due to advanced hepatocellular carcinoma
Outcomes
Primary Outcome Measures
characteristic of Perfusion MR
Ktrans (volume transfer constant between the EES and the blood plasma), Kep (rate constant between the EES and the blood plasma), Ve (Ktrnas/Kep: EES fractional volume), tumor volume
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01336452
Brief Title
Noninvasive Surrogate Marker for Advanced Hepatocellular Carcinoma Response to Concurrent Chemoradiotherapy: MR Perfusion, Contrast Enhanced Ultrasound and Biomarkers
Official Title
Noninvasive Surrogate Marker for Advanced Hepatocellular Carcinoma Response to Concurrent Chemoradiotherapy: MR Perfusion, Contrast Enhanced Ultrasound and Biomarkers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hepatocellular carcinoma is the sixth most common malignancy and the third most common cause of cancer-related death worldwide. The incidence of HCC is rising in Europe and the United States and is expected to continue to increase during the next 2 to 3 decades. The expected survival rate is still decimal, especially in patients with advanced HCC. However, in recent years, several treatment methods for patients with advanced HCC, including antiangiogenic chemotherapy, radiotherapy, concurrent chemoradiotherapy, and DC bead transarterial chemoembolization, have been developed. Among these new treatment methods, concurrent chemoradiotherapy has also proved to increase patient's survival rate. It is important to predict treatment response before treatment or immediately after treatment because there are several other treatment options as mentioned above. Recently, there have been several reports that MR perfusion parameters such as Ktrans can predict treatment response in cervical cancer and colorectal cancer. Therefore the purpose of the investigators study is to evaluate the feasibility of predicting treatment response by MR perfusion, contrast enhanced ultrasound parameters and biomarkers (IL-6, IL-12 and VEGF) in patients with advanced hepatocellular carcinoma who undertake concurrent chemoradiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Adult Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CCRTx
Arm Type
Other
Arm Description
consecutive patients who plan to undertake CCRTx due to advanced hepatocellular carcinoma
Intervention Type
Radiation
Intervention Name(s)
DCE MRI
Intervention Description
DCE (dynamic contrast enhanced) MRI will be obtained just before CCRTx and immediately after finishing CCRTx with 0.1mmol/kg of MR contrast media; CEUS will be obtained just before CCRTx, immediately after finishing CCRTx, and 1 month after CCRTx with 2.4 mL of SonoVue. Blood sampling for biomarker analysis will be performed just before CCRTx, immediately after finishing CCRTx, and 1 month after CCRTx (20mL)
Primary Outcome Measure Information:
Title
characteristic of Perfusion MR
Description
Ktrans (volume transfer constant between the EES and the blood plasma), Kep (rate constant between the EES and the blood plasma), Ve (Ktrnas/Kep: EES fractional volume), tumor volume
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have advanced hepatocellular carcinoma and plan to undertake concurrent chemoradiotherapy.
Patients willing to undergo the study procedure
Patients who are fully informed about the study and have signed the informed consent form
Exclusion Criteria:
Patients (men or women) under 20 years of age
Patients who have been received any other treatment including TACE, operation, TACI, systemic chemotherapy, intraarterial chemotherapy, antiangiogenic therapy
Patients who have hypersensitivity to MR or US contrast agents
Women who are pregnant, lactating or who are of childbearing potential and have not had a negative pregnancy test at baseline visit
Patients not eligible to contrast media injection according to product labeling
Patients with a contraindication for MRI or CT
Patients with impaired renal function (e.g. acute renal failure) or patients on dialysis
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong-Eun Chung, MD, Ph.D
Phone
82-2-2228-7400
Email
radpms@yuhs.ac
12. IPD Sharing Statement
Learn more about this trial
Noninvasive Surrogate Marker for Advanced Hepatocellular Carcinoma Response to Concurrent Chemoradiotherapy: MR Perfusion, Contrast Enhanced Ultrasound and Biomarkers
We'll reach out to this number within 24 hrs