An observational study in Hepatocellular Carcinoma (HCC), sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2019-06-10.
Sponsored by Medical College of Wisconsin · Observational
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.
3,183 studies on the registry are indexed under Carcinoma, Hepatocellular; 955 are open to participants now.
This study's enrollment of 23 is below the median of 200 across 754 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 119 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with hepatocellular carcinoma (HCC or cancer of the liver) and will soon undergo one or more transcatheter arterial chemoembolization (TACE) procedure(s).
Reasons may include
Exclusion Criteria:
HCC patients who have undergone conventional lipiodol based chemoembolization.
Other: MRI post-TACE
Perform lipiodol delivery measurements with MRI post-TACE.
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.
Time frame: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Medical College of Wisconsin