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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

About this trial

This is an interventional diagnostic trial for Colorectal Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT01318239

First Posted

March 17, 2011

Last Updated

March 4, 2014

Sponsor

Yonsei University

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

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

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

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