This single-arm prospective study will compare CT-based tumor-to-normal ratio (TNR) measurements obtained using TriNav versus endhole microcatheters.
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
At least one lesion ≥ 3.0 cm in shortest dimension
Negative pregnancy test in premenopausal women with an acceptable contraception
Contraindications to angiography and selective visceral catheterization
Evidence of potential delivery of greater than 30 Gy absorbed dose to the lungs with a single treatment session
CT based TNR of 3 or higher based on planning hybrid angioCT
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)
Single group
Y90 Microsphere Therapy
DeviceGiven by injection
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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M.D. Anderson Cancer Center
Lead sponsor
TriSalus Life Sciences, Inc.
Collaborator
