TriNav Infusion System for the Evaluation of Fidelity Between 99mTc-MAA and Y90-Microspheres Hepatic Distribution for Dosimetry Treatment Planning

To learn if using the TriNav Infusion System (TriNav catheter) for the injection of the surrogate/test dose during the planning part of the radioembolization procedure and your actual treatment with the radioactive microspheres match each other better than the standard catheter.

Inclusion Criteria:Patients over 18 years of age, of any race or sex, who have unresectable primary or metastatic tumors of the liver, and who are able to give informed consent.Patients must be eligible for Y90-radioembolization treatment, have an ECOG Performance Status score of ≤ 2, with a life expectancy of ≥ 3 months, and must be non-pregnant with an acceptable contraception in premenopausal women.At least one lesion ≥ 3.0 cm in shortest dimensionNegative pregnancy test in premenopausal womenExclusion Criteria:Contraindications to angiography and selective visceral catheterizationEvidence of potential delivery of greater than 30 Gy absorbed dose to the lungs with a single injection.Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (eg, placing catheter distal to gastric vessels)Infiltrative tumorsTarget vessel sizes outside of TriNav device prescribed diameter range of 1.5 - 3.5 mm