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Noninvasive Surrogate Marker for Advanced Hepatocellular Carcinoma Response to Concurrent Chemoradiotherapy: MR Perfusion, Contrast Enhanced Ultrasound and Biomarkers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Yonsei University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Yonsei University Identifier:
First received: April 13, 2011
Last updated: June 1, 2013
Last verified: June 2013
Hepatocellular carcinoma is the sixth most common malignancy and the third most common cause of cancer-related death worldwide. The incidence of HCC is rising in Europe and the United States and is expected to continue to increase during the next 2 to 3 decades. The expected survival rate is still decimal, especially in patients with advanced HCC. However, in recent years, several treatment methods for patients with advanced HCC, including antiangiogenic chemotherapy, radiotherapy, concurrent chemoradiotherapy, and DC bead transarterial chemoembolization, have been developed. Among these new treatment methods, concurrent chemoradiotherapy has also proved to increase patient's survival rate. It is important to predict treatment response before treatment or immediately after treatment because there are several other treatment options as mentioned above. Recently, there have been several reports that MR perfusion parameters such as Ktrans can predict treatment response in cervical cancer and colorectal cancer. Therefore the purpose of the investigators study is to evaluate the feasibility of predicting treatment response by MR perfusion, contrast enhanced ultrasound parameters and biomarkers (IL-6, IL-12 and VEGF) in patients with advanced hepatocellular carcinoma who undertake concurrent chemoradiotherapy.

Condition Intervention
Advanced Adult Hepatocellular Carcinoma
Radiation: DCE MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Noninvasive Surrogate Marker for Advanced Hepatocellular Carcinoma Response to Concurrent Chemoradiotherapy: MR Perfusion, Contrast Enhanced Ultrasound and Biomarkers

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • characteristic of Perfusion MR [ Time Frame: 1 month ]
    Ktrans (volume transfer constant between the EES and the blood plasma), Kep (rate constant between the EES and the blood plasma), Ve (Ktrnas/Kep: EES fractional volume), tumor volume

Estimated Enrollment: 30
Study Start Date: April 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
consecutive patients who plan to undertake CCRTx due to advanced hepatocellular carcinoma
Radiation: DCE MRI
DCE (dynamic contrast enhanced) MRI will be obtained just before CCRTx and immediately after finishing CCRTx with 0.1mmol/kg of MR contrast media; CEUS will be obtained just before CCRTx, immediately after finishing CCRTx, and 1 month after CCRTx with 2.4 mL of SonoVue. Blood sampling for biomarker analysis will be performed just before CCRTx, immediately after finishing CCRTx, and 1 month after CCRTx (20mL)


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

Inclusion Criteria:

  • Patients who have advanced hepatocellular carcinoma and plan to undertake concurrent chemoradiotherapy.
  • Patients willing to undergo the study procedure
  • Patients who are fully informed about the study and have signed the informed consent form

Exclusion Criteria:

  • Patients (men or women) under 20 years of age
  • Patients who have been received any other treatment including TACE, operation, TACI, systemic chemotherapy, intraarterial chemotherapy, antiangiogenic therapy
  • Patients who have hypersensitivity to MR or US contrast agents
  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01336452

Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Yong-Eun Chung, MD, Ph.D    82-2-2228-7400   
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University Identifier: NCT01336452     History of Changes
Other Study ID Numbers: 4-2010-0566
Study First Received: April 13, 2011
Last Updated: June 1, 2013

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on May 22, 2017