On May 4, 2026 TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the "Company"), an oncology company integrating novel delivery technology with standard of care therapies, and its investigational immunotherapeutic to transform treatment for patients with solid tumors, reported the initiation of patient enrollment for the PREDICTT clinical trial (NCT07444645), a prospective study designed to evaluate its novel Pressure-Enabled Drug Delivery (PEDD) approach in patients with primary or metastatic liver tumors.
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The PREDICTT trial is an investigator-led single-arm, prospective, interventional study designed to evaluate how PEDD impacts tumor targeting and radiation dose distribution. Investigators at The University of Texas MD Anderson Cancer Center will assess the use of the TriNav Infusion System in conjunction with Y90 radioembolization therapy. Specifically, the trial will measure changes in CT-based tumor-to-normal liver ratios and assess how these changes correlate with tumor dose and treatment outcomes.
Advancing Precision Delivery in Liver-Directed Therapy
Y90 radioembolization is a widely used treatment for unresectable liver tumors. However, optimizing delivery to maximize tumor dose while minimizing exposure to healthy liver tissue remains a critical challenge. The PREDICTT study aims to address this by evaluating the TriNav Infusion System, a Pressure-Enabled Drug Delivery device designed to improve microsphere distribution within tumors.
Study Design and Objectives
The PREDICTT (Prospective Evaluation of Pressure-Enabled Delivery and Alterations in CT-Based Tumor-to-Normal Liver Ratio and Tumor Dose) trial is an investigator-led study evaluating the impact of pressure-enabled delivery using the TriNav Infusion System in patients undergoing Y90 radioembolization for liver tumors. The PREDICTT trial will enroll approximately 20 adult patients with unresectable primary or metastatic liver tumors who are eligible for Y90 radioembolization. The trial is led by principal investigator Peiman Habibollahi, M.D., associate professor of Interventional Radiology at UT MD Anderson.
Key objectives include:
Evaluate changes in CT-based tumor-to-normal liver enhancement ratios using the TriNav Infusion System
Correlate imaging-based measurements with tumor dose and microsphere distribution
Evaluate relationships between imaging metrics and post-treatment SPECT/CT findings
Assess safety of the TriNav Infusion System [with Y90] in liver directed therapy
Strengthening Clinical Collaboration
The launch of PREDICTT underscores the continued collaboration between TriSalus Life Sciences and UT MD Anderson.
"This study represents an important step toward optimizing locoregional therapies through advanced delivery technologies," said Richard Marshall, MD at Chief Medical Officer, TriSalus Life Sciences. "We are proud to collaborate with UT MD Anderson to generate clinical evidence that could redefine how Y90 therapies are delivered."
(Press release, TriSalus Life Sciences, MAY 4, 2026, View Source [SID1234665065])