Perfusion and Diffusion Magnetic Resonance Imaging, and Phosphorylation of Circulation Endothelial Cells to Determine Anti-anogenic Effect of Chemotherapeutic Regimens in Colorectal Liver Metastasis Patients
Primary Purpose
Colorectal Cancer
Status
Completed
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 Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients who have single or multiple liver metastasis from colorectal cancer
- Patients willing to undergo the study procedure
- Patients who are fully informed about the study and have signed the informed consent form
- 60 patients (30 patients who will get antiangiogenic agent(Avastin) combined chemotherapy and 30 patients who will get chemotherapy without antiangiogenic agent)
Exclusion Criteria:
- Patients (men or women) under 20 years of age
- Patients who have previously entered this study
- Patients who have received or will receive any investigational drug 48 hours before injection of the study drug or during study participation
- 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 Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Standard Chemotherapy with Avastin
Standard Chemotherapy only
Arm Description
Outcomes
Primary Outcome Measures
MR perfusion parameter
MR perfusion parameter(Ktrans, Kep, Ve)
Secondary Outcome Measures
diffusion parameter
diffusion parameter(ADC; apparent diffusion coefficient)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01318239
Brief Title
Perfusion and Diffusion Magnetic Resonance Imaging, and Phosphorylation of Circulation Endothelial Cells to Determine Anti-anogenic Effect of Chemotherapeutic Regimens in Colorectal Liver Metastasis Patients
Official Title
Study of Perfusion and Diffusion Magnetic Resonance Imaging, and Phosphorylation of Circulation Endothelial Cells to Determine Anti-angiogenic Effect in Patients With Colorectal Liver Metastasis in Chemotherapeutic Regimens Including Avastin
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of our study is to establish the accuracy of the perfusion MRI parameters and the availability of the VEGFR2 signaling assay using phosphospecific flow cytometry in predicting the response of liver metastasis from colorectal cancer to treatment with antiangiogenic agent.
Detailed Description
The purpose of our study is to establish the accuracy of the perfusion MRI parameters and the availability of the VEGFR2 signaling assay using phosphospecific flow cytometry in predicting the response of liver metastasis from colorectal cancer to treatment with antiangiogenic agent.
IRB approval will be obtained to enroll 60 naïve patients (30 patients who will get antiangiogenic agent (Avastin) combined chemotherapy and 30 patients who will get chemotherapy without antiangiogenic agent) with liver metastasis from colorectal cancer. MRI and blood test (VEGFR2 signaling assay) will be undergoing at three time points in the patients with Avastin chemotherapy; at baseline (pretreatment), 3 days after Avastin alone treatment, 3 days after Avastin combined chemotherapy (about 10 days after initial Avastin alone treatment). MRI and blood test (VEGFR2 signaling assay) will be undergoing at two time points in the patients who will get chemotherapy without antiangiogenic agent; at baseline (pretreatment), 3 days after chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Chemotherapy with Avastin
Arm Type
Experimental
Arm Title
Standard Chemotherapy only
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
DCE MRI
Intervention Description
MRI and blood test(VEGFR2 signaling assay) will be undergoing at three time points in the patients with Avastin chemotherapy; at baseline (pretreatment), 3 days after Avastin alone treatment, 3 days after Avastin combined chemotherapy (about 10 days after initial Avastin alone treatment).
MRI and blood test(VEGFR2 signaling assay) will be undergoing at two time points in the patients who will get chemotherapy without antiangiogenic agent; at baseline (pretreatment), 3 days after chemotherapy.
Primary Outcome Measure Information:
Title
MR perfusion parameter
Description
MR perfusion parameter(Ktrans, Kep, Ve)
Time Frame
3 days after administrating avastin
Secondary Outcome Measure Information:
Title
diffusion parameter
Description
diffusion parameter(ADC; apparent diffusion coefficient)
Time Frame
3 days after an anti-cancer medicine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have single or multiple liver metastasis from colorectal cancer
Patients willing to undergo the study procedure
Patients who are fully informed about the study and have signed the informed consent form
60 patients (30 patients who will get antiangiogenic agent(Avastin) combined chemotherapy and 30 patients who will get chemotherapy without antiangiogenic agent)
Exclusion Criteria:
Patients (men or women) under 20 years of age
Patients who have previously entered this study
Patients who have received or will receive any investigational drug 48 hours before injection of the study drug or during study participation
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
12. IPD Sharing Statement
Learn more about this trial
Perfusion and Diffusion Magnetic Resonance Imaging, and Phosphorylation of Circulation Endothelial Cells to Determine Anti-anogenic Effect of Chemotherapeutic Regimens in Colorectal Liver Metastasis Patients
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