Study explores PEDD technology to improve tumor targeting and optimize Y90 treatment outcomes in liver cancer patient
TriSalus Life Sciences, Inc., an oncology-focused company dedicated to improving outcomes for patients with solid tumors through innovative therapeutic strategies, has announced the initiation of patient enrollment for its new clinical study known as the PREDICTT trial. Headquartered in Westminster, Colorado, the company continues to advance its mission of integrating novel drug delivery technologies with established standards of care, alongside the development of its investigational immunotherapies.
The PREDICTT clinical trial (ClinicalTrials.gov Identifier: NCT07444645) represents a significant step forward in evaluating a cutting-edge approach to liver-directed cancer treatment. Specifically, the study is designed to investigate the effectiveness of TriSalus’ proprietary Pressure-Enabled Drug Delivery™ (PEDD™) technology in enhancing treatment delivery to liver tumors. These tumors may be either primary liver cancers or metastatic lesions that have spread from other parts of the body.
This trial is structured as a prospective, single-arm, investigator-led interventional study. Its primary purpose is to assess how the PEDD approach influences tumor targeting, drug distribution, and radiation dosing when used in conjunction with established therapies. By focusing on these parameters, the study aims to generate meaningful clinical data that could improve how therapies are delivered directly to tumors within the liver.
The research is being conducted at The University of Texas MD Anderson Cancer Center, one of the world’s leading institutions in cancer research and treatment. Investigators at MD Anderson will utilize the TriNav® Infusion System, TriSalus’ specialized delivery device, alongside Yttrium-90 (Y90) radioembolization therapy. Y90 radioembolization is a widely used, minimally invasive treatment for patients with liver tumors that cannot be surgically removed.
Y90 therapy involves the delivery of radioactive microspheres directly into the blood vessels feeding the tumor. These microspheres emit radiation that targets and destroys cancer cells while sparing surrounding tissue as much as possible. Despite its effectiveness, one of the ongoing challenges with Y90 therapy is ensuring that the radiation dose is optimally distributed—maximizing exposure to tumor tissue while minimizing damage to healthy liver cells.
The PREDICTT study seeks to address this challenge by incorporating the PEDD technology. This approach uses controlled pressure during infusion to improve the penetration and distribution of therapeutic agents within tumors. By enhancing how microspheres are delivered, PEDD may increase tumor uptake and improve the overall effectiveness of the treatment.
A central component of the study involves evaluating changes in CT-based tumor-to-normal liver ratios. This metric compares how much of the infused material accumulates in tumor tissue versus healthy liver tissue. A higher ratio indicates more targeted delivery to the tumor, which is a critical factor in achieving better treatment outcomes.
Researchers will also examine how these imaging-based measurements correlate with the actual radiation dose delivered to the tumor. Additionally, they will assess how the distribution of microspheres within the liver aligns with post-treatment imaging findings obtained through SPECT/CT scans. These analyses will help determine whether improvements in delivery translate into measurable clinical benefits.
The trial plans to enroll approximately 20 adult patients who have unresectable liver tumors and are eligible for Y90 radioembolization. These patients may have either primary liver cancer or metastatic disease. By focusing on this specific patient population, the study aims to evaluate the technology in a real-world clinical setting where treatment options are often limited.
The study is led by Dr. Peiman Habibollahi, an associate professor of Interventional Radiology at MD Anderson Cancer Center. Under his leadership, the research team will oversee all aspects of the trial, including patient selection, treatment administration, imaging analysis, and outcome evaluation.
Key objectives of the PREDICTT trial include:
- Measuring changes in tumor-to-normal liver enhancement ratios using CT imaging following the use of the TriNav Infusion System
- Correlating imaging findings with tumor radiation dose and microsphere distribution patterns
- Evaluating how these imaging metrics relate to post-treatment SPECT/CT results
- Assessing the safety profile of the TriNav Infusion System when used in combination with Y90 radioembolization
In addition to its scientific goals, the trial also highlights the ongoing collaboration between TriSalus Life Sciences and MD Anderson Cancer Center. This partnership reflects a shared commitment to advancing cancer treatment through innovation, research, and clinical excellence.
According to Dr. Richard Marshall, Chief Medical Officer of TriSalus Life Sciences, the study represents an important milestone in the evolution of liver-directed therapies. He emphasized that optimizing locoregional treatments—those delivered directly to the tumor site—is critical for improving patient outcomes. By leveraging advanced delivery technologies like PEDD, clinicians may be able to enhance the precision and effectiveness of existing therapies.
The collaboration aims not only to generate valuable clinical evidence but also to potentially redefine how Y90 therapies are administered in the future. If successful, the findings from the PREDICTT trial could pave the way for broader adoption of pressure-enabled delivery systems in oncology, particularly for patients with difficult-to-treat liver tumors.
Ultimately, the launch of the PREDICTT trial underscores TriSalus Life Sciences’ broader strategy of combining technological innovation with clinical research to address unmet needs in cancer care. By focusing on improving drug delivery at the tumor level, the company hopes to unlock new possibilities for enhancing treatment efficacy while minimizing side effects.
As patient enrollment begins, the oncology community will be closely watching the outcomes of this study. The results could have meaningful implications not only for liver cancer treatment but also for the broader field of interventional oncology, where precision delivery continues to be a key area of advancement.
About TriSalus Life Sciences
TriSalus Life Sciences® is an oncology focused medical technology company seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies, and with its investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of different therapeutic and technology applications. The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s three FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD) approach to deliver a range of therapeutics: the TriNav® Infusion System and TriNav Infusion System LV for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. The PEDD technology is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. Nelitolimod, the Company’s investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. Patient data generated during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that nelitolimod delivered via the PEDD technology may have favorable immune effects within the liver and systemically. The target for nelitolimod, TLR9, is expressed across cancer types and the mechanical barriers addressed by the PEDD technology are commonly present as well. The Company is in the final stages of data completion for a number of phase 1 clinical trials and will begin exploring partnership opportunities for development.
