NCT05128032

Pressure-enabled Delivery in Radioembolization (TriNav Study)

A Prospective, Randomized, Open-Label Study to Examine The Effects of a Pressure-Enabled Drug Delivery Device on Radiotracer Distribution Compared to a Standard Microcatheter in the Context of Radioembolization

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine if the type of catheter used in the mapping procedure prior to radioembolization improves the delivery of radioactivity to tumor(s) in participants with liver cancer. The name of the devices involved in this study are: * Pressure Enabled Drug Delivery (PEDD)/TriNav Infusion System * Standard 2.4F microcatheter, not otherwise specified

Detailed description

This is a prospective, randomized, open-label, single-center, investigator-initiated study to determine if the type of catheter used to deliver the radiotracer in the mapping procedure improves the delivery of radioactive microspheres during radioembolization treatment for liver cancer. Both catheters being used, the Pressure Enabled Drug Delivery (PEDD)/TriNav Infusion System and theStandard 2.4F microcatheter have been cleared for clinical use by the U.S. Food and Drug Administration. Radioembolization for the treatment of liver tumors typically requires 2 separate procedures. The first procedure is called the mapping procedure. During the mapping procedure, the blood supply to the liver and tumor are evaluated with a type of x-ray called angiography. Once the optimal catheter position is determined for treatment, a "simulation" run is performed with the injection of a fluid that acts like the radiation that will be delivered to treat the tumors. This fluid is called a radiotracer. The study is looking to learn if the Pressure Enabled Drug Delivery device increases the ratio of radiotracer delivered to liver tumor tissue relative to normal liver tissue compared to a standard microcatheter. An improved delivery of radiotracer may indicate improved delivery of radioactive microspheres which may lead to improved tumor response rates and less liver toxicity The research study procedures include assessments for eligibility, study treatment including evaluations, and follow-up visits. Participants will undergo the study procedures in the normal course of their radioembolization procedure, with the addition of a second mapping procedure on the treatment day. Participants will be randomly assigned to one of two mapping procedures: Sequence A or Sequence B. It is expected that about 10-20 people in total will take part in this research study. TriSalus Life Sciences, Inc., a biotechnology and medical device company, is supporting this research study by providing funding.

Conditions

• Liver Cancer
• Hepatocellular Carcinoma
• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	Standard microcatheter	Small device used for mapping as part of radioembolization procedure
DEVICE	PEDD device	Pressure enabled small device used for mapping as part of radioembolization procedure

Timeline

• Start date: 2022-03-01
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2021-11-19
• Last updated: 2026-03-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study