3T MRI to Predict TACE Response of HCC

Study Overview
=================
Brief Summary
-----------------
This study is a prospective clinical study using DCE-MRI, DWI and MRS in 3T scanner to evaluate tumors in patients with unresectable HCC after TACE. A total of 100 subjects will be recruited. MRI will be performed before TACE (day 0), day 14, and day 28 to assess the tumor responses. After day 28, all subjects will receive standard clinical care and be follow-up for 1 year. The imaging parameters will be compared among each MRI and correlate with patients' outcome. The investigators hypothesis that it might be helpful to combine DCE-MRI, DWI, and MRS for assessment of tumor response after TACE and predict patients' prognosis.

Detailed Description
-----------------
Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) is a non-invasive quantitative technique for assessing micro-vascular structure by tracking the pharmacokinetics of injected low-molecular weight contrast agents as they pass through the tumor vasculature. This modality is being increasingly used in many oncological studies to characterize tumor angiogenesis and invasiveness, and monitor the treatment response. Diffusion-weighted imaging (DWI) enables qualitative and quantitative assessment of tissue diffusivity (apparent diffusion coefficient, ADC) without the use of gadolinium chelates. DWI has been suggested to be useful in monitoring the response of HCC after TACE because of earlier assessment of tumor necrosis with increasing ADC values. MR spectroscopy facilitates the study of cellular metabolism and in vivo detection of abnormalities. A few studies of in vivo MR spectroscopy reported an increase in choline levels within tumors such as HCC and a reduction in the lipid-to-choline ratio after conventional TACE was performed for HCC.

Official Title
-----------------
Combination of Dynamic Contrast-enhanced and Diffusion-weighted Imaging and Magnetic Resonance Spectroscopy in 3T MRI to Early Predict Treatment Efficacy in Patients Receiving Transarterial Chemoembolization for Hepatocellular Carcinoma

Conditions
-----------------
Carcinoma, Hepatocellular

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prior Informed Consent Form Patients who had undergone surgery for the treatment of HCC are allowed. At least one measurable tumor, according to RECIST version 1.1. Age more than 20 years. ECOG performance status 0 or 1. Life expectancy more than 3 months. Child-Pugh class A. Unresectable, multinodular tumors Confirmed Diagnosis of HCC At least one uni-dimensional lesion measurable according to the Modified RECIST criteria by MRI Adequate bone marrow, liver and renal function Exclusion Criteria: History of TACE Diffuse infiltrative HCC or presence of main portal vein invasion or extrahepatic metastasis Any contraindications for hepatic embolization procedures:, including hepatofugal blood flow, large intrahepatic or porto-systemic shunt, impaired clotting test, renal failure requiring hemo-or peritoneal dialysis Any contraindication for MRI, including known contrast allergy, electronically operated implants or devices, and claustrophobia. Other acute or chronic medical, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and is inappropriate for this study by the judgment of the investigator Known history of HIV infection Concurrent primary extrahepatic cancer Pregnant or breast-feeding subjects

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TACE patients, for HCC<br>unresectable HCC patients | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor response | change of tumor size from baseline to at 6 months | change of tumor size from baseline to at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of baseline MRI parameters | comparsion of MRI parameters from baseline to 6 months | change of MRI parameters from baseline to at 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular carcinoma, Transarterial chemoembolization, Magnetic resonance imaging