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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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Yonsei University

Status

Completed

Conditions

Colorectal Cancer

Treatments

Procedure: DCE MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT01318239
4-2010-0047

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

37 participants in 2 patient groups

Standard Chemotherapy with Avastin
Experimental group
Treatment:
Procedure: DCE MRI
Standard Chemotherapy only
Active Comparator group
Treatment:
Procedure: DCE MRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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