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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

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ClinicalTrials.gov Identifier: NCT01318239
Recruitment Status : Completed
First Posted : March 18, 2011
Last Update Posted : March 5, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: DCE MRI Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : July 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Standard Chemotherapy with Avastin 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.

Active Comparator: Standard Chemotherapy only 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.




Primary Outcome Measures :
  1. MR perfusion parameter [ Time Frame: 3 days after administrating avastin ]
    MR perfusion parameter(Ktrans, Kep, Ve)


Secondary Outcome Measures :
  1. diffusion parameter [ Time Frame: 3 days after an anti-cancer medicine ]
    diffusion parameter(ADC; apparent diffusion coefficient)



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318239


Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01318239     History of Changes
Other Study ID Numbers: 4-2010-0047
First Posted: March 18, 2011    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents