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

Yonsei University37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

DCE MRIPROCEDURE

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

MR perfusion parameter

MR perfusion parameter(Ktrans, Kep, Ve)

Time frame: 3 days after administrating avastin

Secondary Outcomes

diffusion parameter

diffusion parameter(ADC; apparent diffusion coefficient)

Time frame: 3 days after an anti-cancer medicine

Data from ClinicalTrials.gov

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