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Completed

NCT Number: NCT01318239

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital

Seoul, 120-752, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. MR perfusion parameter

    Time frame: 3 days after administrating avastin

    MR perfusion parameter(Ktrans, Kep, Ve)

Secondary outcomes

  1. diffusion parameter

    Time frame: 3 days after an anti-cancer medicine

    diffusion parameter(ADC; apparent diffusion coefficient)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 18, 2011
Registry last updated
Mar 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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