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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318239
• Other study ID #: 4-2010-0047
• Status: Completed
• Phase: N/A
• First received: March 17, 2011
• Last updated: March 4, 2014
• Start date: July 2010
• Est. completion date: April 2013

Study information

• Verified date: March 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer

Intervention

Procedure:
• DCE MRI
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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MR perfusion parameter	MR perfusion parameter(Ktrans, Kep, Ve)	3 days after administrating avastin	No
Secondary	diffusion parameter	diffusion parameter(ADC; apparent diffusion coefficient)	3 days after an anti-cancer medicine	No