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

Not Applicable

• Conditions: Advanced Adult Hepatocellular Carcinoma
• Interventions: Radiation: DCE MRI

• Registration Number: NCT01336452
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-13
• Study First Submitted QC: 2011-04-14
• Study First Posted: 2011-04-15
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-01
• Last Update Posted: 2013-06-04
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CCRTx	DCE MRI	consecutive patients who plan to undertake CCRTx due to advanced hepatocellular carcinoma

Primary Outcome Measures

Name	Time	Method
characteristic of Perfusion MR	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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of