This early phase I trial compares end hole catheters to pressure-modulated delivery catheter (TriNav catheter) in patients undergoing transarterial chemoembolization (TACE) in patients with liver and neuroendocrine cancer that has spread to the liver (liver metastases). Hepatocellular cancer, or HCC, and neuroendocrine tumor (NET) are two forms of cancer involving the liver which often cannot be removed with surgery. Transarterial chemoembolization, or simply TACE is a procedure in which chemotherapy (medicines toxic to the cancer) is given from inside the blood vessels supplying the tumor with oxygen and nutrients, followed by embolization (intentional blockage) of these blood vessels. The goal of this study is to examine the ability of two catheter types to fill the tumor with the chemotherapy mixture in TACE. Information gathered from this study may help researcher understand how end hole compared to pressure-modulated delivery catheter may improve TACE delivery in treating patients with HCC and NET with liver metastases.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06204159.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer CenterStatus: Temporarily closed to accrual
Contact: Gregory Nadolski
Phone: 267-251-9926
PRIMARY OBJECTIVE:
I. To estimate the volume and density of lipiodol deposition in HCC and NET metastases with end hole versus (vs.) pressure-modulated catheter delivery.
SECONDARY OBJECTIVES:
I. To estimate the following measures in HCC and NET metastases with end hole and pressure-modulated delivery:
Ia. Volumetric necrosis;
Ib. Response by modified Response Evaluation Criteria in Solid Tumors (mRECIST);
Ic. Rate of local progression.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo two TACEs using end hole catheter, followed by TriNav catheter approximately 4 weeks later. Patients also undergo magnetic resonance imaging (MRI) and CT throughout the study.
ARM II: Patients undergo two TACEs using TriNav catheter, followed by an end hole catheter approximately 4 weeks later. Patients also undergo MRI and CT throughout the study.
After completion of study treatment, patients are followed up until first recurrence, progression of disease, or 24 months after the initial TACE.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorGregory Nadolski
