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Participants with either hepatocellular carcinoma (HCC) or colorectal liver metastases tumors receiving standard of care radioembolization treatment will be randomly assigned to undergo a routine mapping procedure first using a standard microcatheter 2-21 days before their radioembolization treatment day. Then on day of radioembolization treatment, an extra mapping procedure using the PEDD device catheter will be done just prior to the treatment.

Participants with either hepatocellular carcinoma (HCC) or colorectal liver metastases tumors receiving standard of care radioembolization treatment will be randomly assigned to undergo a routine mapping procedure first using the PEDD device catheter 2-21 days before their radioembolization treatment day. Then on day of radioembolization treatment, an extra mapping procedure using a standard microcatheter will be done just prior to the treatment.

Small device used for mapping as part of radioembolization procedure

Standard microcatheter

Pressure enabled small device used for mapping as part of radioembolization procedure

PEDD device

Patrick D Sutphin, MD, PhD

Ammar Sarwar, MD

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

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.

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

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

The primary endpoint of the study is radiotracer distribution, as measured by tumor to normal liver (T:N) ratio. Using SPECT/CT images collected subsequent to radiotracer delivery in mapping procedures, the volumetric tumor to normal liver (T:N) ratio of 99mTc-MAA distribution will be calculated using advanced imaging processing software, such as MIM SurePlan MRT. The T:N ratio of 99mTc-MAA delivered via the standard microcatheter will be compared to the PEDD device for each patient. The T:N ratio will be calculated for each tumor as well as in aggregate for the three largest tumors as described in Section 12.

Compare the mapping procedure radiotracer T:N ratio to therapeutic microsphere T:N ratio for both the standard microcatheter and the PEDD device when both the radiotracer and therapeutic microspheres were delivered by the same catheter

Technical success of radiotracer delivery of each catheter, where success is defined as the satisfactory positioning and delivery of radiotracer.

Spots Global Cancer Trial Database for standard microcatheter