Can Quantitative MRI After cTACE Help Predict Survival ?

Study Overview
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Brief Summary
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Transcatheter arterial chemoembolization (TACE) is a widely accepted palliative therapy for the treatment of HCC. Palliative means that it does not cure the disease prolongs your life and improves quality of life. During TACE, a mixture of chemotherapy drugs is combined with an oil called lipiodol. Lipiodol has a role as both drug carrier and embolic agent (a material that blocks blood flow to tumors). The lipiodol/chemotherapy mixture is injected into an artery (blood vessel) directly supplying blood to a HCC tumor. Lipiodol is made up of fat and water which can be seen on MRI. Therefore, MRI can be used to quantify the amount of lipiodol delivered to the HCC tumors. In this study, the investigators want to see if patient survival is related to the amount of lipiodol delivered to HCC tumors.

Official Title
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Can Quantitative MRI After Conventional Transarterial Chemoembolization (cTACE) Help Predict Survival ?

Conditions
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Hepatocellular Carcinoma (HCC)

Intervention / Treatment
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* Other: MRI post-TACE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prospective studies will be performed in 20 patients with Hepatocellular Carcinoma (HCC) independently scheduled to undergo TACE; tumors in each of these candidates will already have been deemed un-resectable. Reasons may include concurrent co-morbidities including cardiac or respiratory compromise recurrent or multi-lobar disease cirrhosis or portal hypertension vascular invasion high tumor burden contraindications to general anesthesia. Diagnosis of HCC will have been established by a) biopsy or b) non-invasively, based upon > 2cm diameter tumor with characteristic imaging findings in the setting of cirrhosis. Male or female aged 18 to 89 years, all ethnicities Exclusion Criteria: Infiltrative or diffuse HCC. Does not meet inclusion criteria. Pregnant women. Individuals with pacemakers or other non-MRI compatible metallic implants. Hemodialysis patients or patients with severely impaired renal function. Individuals with severe claustrophobia or unwilling to get a MRI.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCC patients having MRI post-TACE<br>HCC patients who have undergone conventional lipiodol based chemoembolization. | Other: MRI post-TACE<br>* Perform lipiodol delivery measurements with MRI post-TACE.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging response | Imaging response will be assessed according to 3D European Association for the Study of the Liver (EASL) criteria. EASL criteria propose using contrast enhanced (CE) images to measure viable volumes. We will transfer all images to a computer workstation. We will measure 'viable' enhancing tumor volumes at each interval and percent change in viable tumor volume (change from baseline). We will correlate lipiodol delivery measurements to primary outcomes post-therapy. | Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response | Clinical response will be measured using Eastern Cooperative Oncology Group (ECOG) performance status classification. We will consider a change of 0.5 ECOG levels to be clinically significant. | Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death. | 
| Adverse Events | Adverse Events will be measured according to the Common Terminology Criteria (NCI CTC) version 3.0 criteria for each patient. We will define Grades 0-2 as tolerance to therapy and Grades 3 or 4 as toxic. | Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death. | 
| Time-to-Tumor Progression | Time-to-tumor progression will be assessed by monitoring viable tumor volumes post-TACE and defining progression as a >44% volume increase (3D EASL criteria). | Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death. | 
| Survival | We will determine the number of days from first treatment to last follow-up to calculate the median days of overall survival after first treatment. | Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular, Carcinoma, lipiodol, HCC