Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery

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) fordistinct 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 ≤5times 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 atleast 1 month prior to screening and agreement to use such contraception frombeginning of study treatment until 1 month following last TACE treatment, asrecommended for TACE treatments not conducted within the trial.

• For males of reproductive potential: use of condoms or other methods to ensureeffective contraception with partner from first study treatment until 1 monthfollowing last TACE treatment.

• Provision of signed and dated informed consent form and ability to consent foroneself.

• Stated willingness to comply with all study procedures and availability for thestudy duration.

Exclusion Criteria:

• Absolute contraindication to contrast-enhanced MRI

• Absolute contraindication to intravenous iodinated contrast, including history ofprevious severe contrast reaction or moderate reaction not mitigated by appropriatepre-medication

• Pregnancy or lactation

• Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenalpapilla

• Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements