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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


N/A
20 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

MR perfusion parameter

Outcome Description:

MR perfusion parameter(Ktrans, Kep, Ve)

Outcome Time Frame:

3 days after administrating avastin

Safety Issue:

No

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

4-2010-0047

NCT ID:

NCT01318239

Start Date:

July 2010

Completion Date:

April 2012

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms
  • Neoplasm Metastasis

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