This clinical trial evaluates whether a pressure enabled drug delivery device called the TriNav Infusion System improves the amount of yttrium-90 (Y90) microspheres delivered to tumor tissue versus normal tissue in patients undergoing Y90 microsphere radioembolization for primary liver tumors that cannot be removed by surgery (unresectable) or tumors that have spread to the liver from another primary site (metastatic). Y90 therapy is an accepted treatment for many types of cancer, including cancers of the liver. However, accurate dosing is important for improvements in treatment response and patient outcomes, and personalized dosimetry is often used for planning Y90 treatment. Personalized dosimetry planning for Y90 treatment typically involves the measurement of the tumor to normal liver ratio using standard pre-treatment mapping studies to determine the treatment and dose. Pressure enabled drug delivery systems like the TriNav Infusion System use microcatheters to control intra-arterial pressure and blood flow dynamics in the tumor and normal liver tissues while administering treatment. This may increase the delivery of Y90 to tumor tissue and decrease its delivery to normal liver tissues.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07444645.
Locations matching your search criteria
United States
Texas
Houston
UT MD Anderson Cancer CenterStatus: Active
Contact: Peiman Habibollahi
PRIMARY OBJECTIVE:
I. To evaluate the alterations in computed tomography (CT)-based relative enhancement ratio from non-contrast to post-contrast CT imaging in the tumor and normal liver with an Food and Drug Administration (FDA)-cleared pressure enabled drug delivery (Trademark) (PEDD[TM]) device aka TriNav Infusion System.
SECONDARY OBJECTIVES:
I. To evaluate the correlation of CT-based relative enhancement with tumor to normal liver ratio (TNR) from technetium Tc-99m albumin aggregated (Tc99m-MAA) single photon emission computed tomography (SPECT)/CT mapping study, and tumor dose (TD), nontumoral liver dose (NTLD), and tumor microparticle load from the post-Y90 treatment SPECT/CT in patients mapped and treated with TriNav Infusion System.
II. To assess safety of TriNav catheter in this study population.
OUTLINE:
MAPPING DAY: Patients undergo standard angiography and computed tomography angiography (angioCT) to determine planned site for Y90 treatment and then undergo placement of the TriNav Infusion System catheter in the planned site of treatment. Patients again undergo standard angioCT and then receive Tc-99m MAA via the TriNav Infusion System.
TREATMENT DAY: Patients undergo placement of the TriNav Infusion System catheter in the planned treatment site. Patients then undergo Y90 microsphere radioembolization treatment with Y90 microspheres delivered using the TriNav Infusion System.
Patients also undergo standard of care (SOC) SPECT/CT on study.
After completion of study intervention, patients are followed up at 90 and 180 days.
Trial PhaseNo phase specified
Trial Typedevice
Lead OrganizationUT MD Anderson Cancer Center
Principal InvestigatorPeiman Habibollahi
