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

NCT01318239 | Completed DMC

• 1 other identifier: 4-2010-0047
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• MR perfusion parameter

  MR perfusion parameter(Ktrans, Kep, Ve)

  3 days after administrating avastin

Secondary Outcomes (1)

• diffusion parameter

  3 days after an anti-cancer medicine

Study Arms (2)

Standard Chemotherapy with Avastin

EXPERIMENTAL

Procedure: DCE MRI

Standard Chemotherapy only

ACTIVE COMPARATOR

Procedure: DCE MRI

Interventions

DCE MRI PROCEDURE

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.

Standard Chemotherapy only; Standard Chemotherapy with Avastin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• patients (30 patients who will get antiangiogenic agent(Avastin) combined chemotherapy and 30 patients who will get chemotherapy without antiangiogenic agent)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2011
• First Posted: March 18, 2011
• Study Start: July 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

KR (1)