Pressure-enabled Delivery in Radioembolization (TriNav Study)

Inclusion Criteria:

• Known HCC or CLM that are not amenable to curative resection or thermal ablativetechniques such as microwave ablation.

• Prior clinical decision for treatment by radioembolization.

• Disease that is visible on CT or MRI as well as measurable disease in the liver.Measurable is defined as at least one lesion in the expected treatment field thatcan be accurately measured in at least one dimension (longest diameter) as (≥1 cm)with CT scan or MRI.

• Age ≥18 years. Because there is limited data with respect to radioembolization inpatients <18 years of age with respect to tumor dosimetry and associated adverseevents participants <18 years of age, children are excluded from this study.

• ECOG performance status < 2 (Karnofsky ≥60%, see Appendix A).

• Life expectancy >16 weeks.

• Suitable target artery diameter(s), defined in the TriNav labelling as 1.5 to 3.5mmvessels, based upon pre-procedural imaging.

• Adequate organ and marrow function as defined below:

• International Normalized Ratio (INR): ≤ 1.5

• Hemoglobin: ≥ 8.5 g/dL

• Leukocytes: ≥2,000/mcL

• Absolute neutrophil count: ≥1,00/mcL

• Platelets: ≥50,000/mcL(after transfusion, if necessary)

• Total bilirubin: ≤2.0 mg/dL

• Albumin: ≥3 g/dL

• AST(SGOT)/ALT(SGPT): ≤6 × institutional ULN

• Glomerular filtration rate (GFR): 30 mL/min/1.73 m2

• Child Pugh Score A, or B7 with bilirubin ≤ 2 mg/dL.

• If extrahepatic disease is present (e.g. brain metastases), such disease must bestable, under treatment, or not an imminent threat to the patient's life or qualityof life.

• Ability to understand and the willingness to sign a written informed consentdocument.

• Prior to study entry women of child-bearing potential must agree to not becomepregnant, nurse a baby, or use any milk expressed for 2 weeks followingradioembolization. Men must agree to not father a baby for 2 months after treatmentwith radioembolization (This is confirmed during the consenting process anddocumented when the patient signs the informed consent form. The effects ofYttrium-90 and radiation associated with the procedures, radiotracers, andsubsequent imaging are known to have teratogenic effects on the developing humanfetus. Should a woman become pregnant or suspect she is pregnant while she or herpartner is participating in this study, she should inform her treating physicianimmediately. Because there is an unknown but potential risk for adverse events innursing infants secondary to treatment of the mother breastfeeding should bediscontinued for the duration of study participation.)

• For HCC patients: Barcelona Clinic Liver Cancer Stage: A, B, C.

Exclusion Criteria:

• Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycinC) prior to entering the study.

• Unresolved toxicities related to cancer therapy that the investigator will continueand compromise patient safety.

• History of hepatic encephalopathy; history of severe peripheral allergy orintolerance to contrast agents, narcotics, sedatives, or atropine that cannot bemanaged medically.

• Uncontrolled intercurrent illness.

• Psychiatric illness/social situations that would limit compliance with studyrequirements.

• Prior external beam radiation treatment to the liver or prior intra-arterialliver-directed therapy including transarterial bland embolization, chemoembolizationor radioembolization.

• Contraindications to angiography and selective visceral catheterization, includingbleeding diathesis or uncorrectable coagulopathy.

• > 50% of tumor involvement of the liver.

• Receipt of intervention for the Ampulla of Vater or compromise thereof.

• Child-Pugh B8 or greater.

• Evidence of thrombosis in the main portal vein.

• For CLM patients: evidence of cirrhosis or portal hypertension.

• For CLM: Clinically-evident ascites other than trace noted on imaging.