Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery

Hepatocellular (HCC) and neuroendocrine (NET) liver metastases undergoing Lipiodol transarterial chemoembolization (TACE) will be randomized to endhole vs. pressure-modulated catheter delivery. Lipiodol deposition will be quantified and correlated with volumetric necrosis, response, and local progression.

Inclusion criteria

• Male or female, aged >18 years.
• Plan to undergo lipiodol TACE for HCC or NET liver metastases
• Bilobar disease or distribution for which staged therapy (more than one TACE) for distinct target tumors is planned
• Liver tumor burden does not exceed 50% of the liver volume
• Patent main portal vein
• Life expectancy of greater than 6 months
• ECOG performance status 0-2
• Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl
• Adequate marrow and renal function as defined as:
• Platelets >75,000/mcL (may be corrected by transfusion)
• Serum creatinine < 2.0 mg/dl
• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such contraception from beginning of study treatment until 1 month following last TACE treatment, as recommended for TACE treatments not conducted within the trial.
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner from first study treatment until 1 month following last TACE treatment.
• Provision of signed and dated informed consent form and ability to consent for oneself.
• Stated willingness to comply with all study procedures and availability for the study duration.

Exclusion criteria

• Absolute contraindication to contrast-enhanced MRI
• Absolute contraindication to intravenous iodinated contrast, including history of previous severe contrast reaction or moderate reaction not mitigated by appropriate pre-medication
• Pregnancy or lactation
• Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements