This clinical trial compares a pressure-enabled drug delivery (PEDD) device to standard microcatheter for radiotracer delivery for mapping liver cancer or cancer that has spread to the liver (liver metastases) before radioembolization. Radioembolization refers to the delivery of radioactivity directly to the tumor through the artery that provides the blood supply to the tumor. The radioactivity is delivered in the form of tiny radioactive beads, known as microspheres, through a catheter that is positioned in the artery supplying the tumor. The radioactive microspheres stay in the arteries of the tumor and deliver a high dose of radiation to kill the tumor. Before a radioembolization procedure, another procedure called "mapping" is performed to look at the anatomy of tumors and their arteries in order to determine the right dose of radioactivity. Mapping is also used to plan where the radioactivity will be put to best protect the healthy tissue around the tumor and healthy organs. The purpose of the study is to determine if the type of catheter used in the mapping procedure improves the delivery of radioactivity to the tumor, which may lead to improved tumor response rates and less liver toxicity.
Additional locations may be listed on ClinicalTrials.gov for NCT05128032.
Locations matching your search criteria
United States
Massachusetts
Newton
Newton-Wellesley HospitalStatus: Active
Contact: Patrick D. Sutphin
PRIMARY OBJECTIVE:
I. To compare the ratio of tumor to normal liver distribution of radiotracer, technetium-labeled macroaggregated albumin (99mTc-MAA), delivered via a Pressure Enabled Drug Delivery (PEDD) device (TriNav Infusion System, TriSalus Life Sciences, Westminster, Colorado), compared with a standard microcatheter.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive technetium Tc-99m albumin aggregated via standard microcatheter and undergo angiography and/or computed tomography (CT). Within 2-21 days, patients receive technetium Tc-99m albumin aggregated via PEDD device and undergo angiography and/or CT. Patients then undergo standard of care radioembolization and may undergo positron emission tomography (PET)/CT on study. Patients also undergo CT or magnetic resonance imaging (MRI) throughout the study.
ARM II: Patients receive technetium Tc-99m albumin aggregated via PEDD device and undergo angiography and/or CT. Within 2-21 days, patients receive technetium Tc-99m albumin aggregated via standard microcatheter and undergo angiography and/or CT. Patients then undergo standard of care radioembolization and may undergo PET/CT on study. Patients also undergo CT or MRI throughout the study.
After completion of study intervention, patients are followed up at 30 and 120 days.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorPatrick D. Sutphin
