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 because the information has not been verified recently.

Verified April 2011 by Yonsei University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Yonsei University

ClinicalTrials.gov Identifier:

NCT01336452

First received: April 13, 2011

Last updated: April 14, 2011

Last verified: April 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	April 13, 2011
Last Updated Date	April 14, 2011
Start Date ^ICMJE	April 2011
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01336452 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Noninvasive Surrogate Marker for Advanced Hepatocellular Carcinoma Response to Concurrent Chemoradiotherapy: MR Perfusion, Contrast Enhanced Ultrasound and Biomarkers
Official Title ^ICMJE	Noninvasive Surrogate Marker for Advanced Hepatocellular Carcinoma Response to Concurrent Chemoradiotherapy: MR Perfusion, Contrast Enhanced Ultrasound and Biomarkers
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Advanced Adult Hepatocellular Carcinoma
Intervention ^ICMJE	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)
Study Arm (s)	CCRTx consecutive patients who plan to undertake CCRTx due to advanced hepatocellular carcinoma Intervention: Radiation: DCE MRI
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	March 2013
Estimated Primary Completion Date	March 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	20 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01336452
Other Study ID Numbers ^ICMJE	4-2010-0566
Has Data Monitoring Committee	No
Responsible Party	Yong-Eun Chung / Clinical Assistant Professor, Severance Hospital, Department of Diagnostic Radiology
Study Sponsor ^ICMJE	Yonsei University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yonsei University
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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