TriNav Infusion System for Liver Cancer

Overseen By Armeen Mahvash, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Angiography contraindications, Lung dose >30 Gy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the TriNav Infusion System, a specialized catheter, can enhance the precision of liver cancer treatment. The system injects a test dose during the planning stage of radioembolization, a procedure targeting liver tumors with radioactive particles. The goal is to ensure the test dose and actual treatment align more closely than with standard methods. Suitable participants have liver tumors that cannot be surgically removed and plan to receive Y90-radioembolization. As an unphased trial, this study allows patients to contribute to innovative research that could improve future liver cancer treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the TriNav Infusion System is safe for liver cancer treatment?

Research has shown that the TriNav Infusion System is promising in terms of safety for liver cancer treatments. Studies have examined how effectively this system delivers drugs directly into tumors. These studies found no major safety issues, suggesting the treatment is generally safe.

Other research has linked the TriNav Infusion System to better outcomes, such as a higher rate of liver transplants. While this doesn't directly address safety, it suggests the system may be beneficial without causing significant harm.

Overall, current evidence supports the safety of the TriNav Infusion System, with no major side effects reported. This makes it a potentially good option for those considering joining a clinical trial for liver cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The TriNav Infusion System is unique because it aims to enhance the precision of radioembolization procedures for liver cancer. Unlike traditional catheters, the TriNav catheter is designed to ensure that the injection of the test dose during planning more accurately matches the delivery of the radioactive microspheres during actual treatment. This improved accuracy potentially leads to better targeting of cancer cells while sparing healthy tissue, which could enhance treatment effectiveness and minimize side effects. Researchers are excited about this advancement as it could refine the delivery process, making treatments safer and more efficient for patients.

What evidence suggests that the TriNav Infusion System is effective for liver cancer?

Research shows that the TriNav Infusion System, used by participants in this trial, might outperform traditional methods for treating liver cancer. Studies have found that the TriNav system delivers treatment more effectively to liver tumors. It surpasses traditional small tubes used for delivering treatments. Patients using the TriNav system also experienced better outcomes, including higher rates of liver transplants. Early data suggest that this method significantly enhances treatment delivery to liver tumors compared to conventional methods. ^{1 3 6 7 8}

Who Is on the Research Team?

Armeen Mahvash, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with inoperable liver tumors, either primary or metastatic. Participants must have a life expectancy of at least 3 months, an ECOG score ≤2 (which means they can do some activities), and not be pregnant. They should also have at least one tumor that's ≥3 cm big. People who can't undergo angiography or might get too much radiation to their lungs from the treatment cannot join.

Inclusion Criteria

I am not pregnant.

At least one lesion ≥ 3.0 cm in shortest dimension

I am eligible for Y90 treatment, can perform daily activities, expected to live 3+ months, and not pregnant or using contraception if premenopausal.

Exclusion Criteria

Target vessel sizes outside of TriNav device prescribed diameter range of 1.5 - 3.5 mm

My tumor is spreading into surrounding tissues.

I cannot undergo angiography or selective visceral catheterization due to health risks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Planning

Participants undergo treatment planning using the TriNav Infusion System for the injection of the surrogate/test dose during the radioembolization procedure

1-2 weeks

1 visit (in-person)

Treatment

Participants receive actual treatment with the radioactive microspheres using the TriNav Infusion System

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• TriSalus™ TriNav™Infusion System

Trial Overview

The study tests if the TriNav Infusion System improves matching between a test dose and actual radioactive microsphere distribution during radioembolization for liver cancer compared to standard catheters. It aims to see if this system leads to better planning and outcomes.

How Is the Trial Designed?

Group I: TriSalus™ TriNav™Infusion System (catheter) Experimental Treatment 3 Interventions

TriNav Infusion System (TriNav catheter) for the injection of the surrogate/test dose during the planning part of the radioembolization procedure and your actual treatment with the radioactive microspheres match each other better than the standard catheter

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

TriSalus Life Sciences, Inc.

Industry Sponsor

Trials

10

Recruited

420+

TriSalus Life Sciences

Collaborator

Trials

5

Recruited

70+

Published Research Related to This Trial

The totally implantable infusion system offers a safe and effective method for administering intravenous medications in oncology patients, reducing the need for frequent replacements of traditional subclavian lines and minimizing complications.

This system shows a low incidence of complications and no catheter thrombosis, suggesting it may be superior to percutaneous catheters like Broviac and Hickman for delivering chemotherapy, although its use for total parenteral nutrition is still under evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Totally implantable venous access system for cyclic administration of cytotoxic chemotherapy. Bland, KI., Woodcock, T.[2019]

A new method for implanting a catheter-port system for hepatic arterial infusion chemotherapy (HAIC) combines interventional radiology and laparotomy, showing promising results in 13 patients without any cases of hepatic artery occlusion.

This modified approach may simplify the procedure and reduce complications associated with traditional methods, potentially improving the safety and efficacy of long-term HAIC treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatic arterial catheterization combining interventional radiological and laparotomic approaches. Watanabe, M., Takita, W., Nakazaki, H., et al.[2004]

The Seldinger technique for implanting totally implantable venous access ports (TIVAPs) has a higher primary implantation success rate compared to the venous cutdown technique, based on moderate-quality evidence from nine studies involving 1253 participants.

While the overall complication rates were similar between the Seldinger and venous cutdown techniques, the Seldinger technique using the subclavian vein was associated with a higher incidence of catheter complications, although rates of pneumothorax and infection did not differ significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venous cutdown versus the Seldinger technique for placement of totally implantable venous access ports. Hsu, CC., Kwan, GN., Evans-Barns, H., et al.[2021]

In a study of 70 oncology patients using totally implantable intravenous ports (TIVAPs), infections were the most common complication, particularly catheter-associated bloodstream infections, leading to unplanned port extractions.

Higher body mass index (BMI) was identified as an independent risk factor for developing infections related to TIVAPs, suggesting that patients with elevated BMI may require closer monitoring for potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Factors of Catheter-Related Infection in Unplanned Extubation of Totally Implantable Venous-Accessportsin Tumor Patients. Xu, M., Deng, L., Zhu, Y., et al.[2023]

The study reviewed 283 adult cancer patients and found that ultrasound-guided implantation of totally implantable venous access ports (TIVAPs) via the right innominate vein was technically successful in 100% of cases, with a very high first-attempt success rate of 99.3%.

The procedure demonstrated a low complication rate of 2.83%, with only minor issues reported, indicating that this method is both safe and effective for long-term central venous access in chemotherapy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ultrasound-guided totally implantable venous access ports via the right innominate vein in adult patients with cancer: Single-centre experience and protocol. Sun, X., Xu, J., Xia, R., et al.[2019]

A totally implanted drug delivery system for hepatic arterial chemotherapy was successfully evaluated in 13 patients, showing reliable performance with stable flow rates and excellent patient acceptance over a median treatment duration of 6 months.

The system led to partial tumor regressions in 11 out of 13 patients, indicating its efficacy in delivering chemotherapy directly to liver tumors, while allowing patients to maintain normal daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Totally implanted drug delivery system for hepatic arterial chemotherapy. Ensminger, W., Niederhuber, J., Dakhil, S., et al.[2013]

The study involved 33 patients with liver metastases from colorectal tumors who underwent a percutaneous catheter insertion for regional chemotherapy, with an average treatment duration of 27 weeks.

The method demonstrated high patient acceptance and a low therapy drop-out rate of 9% due to catheter-related complications, which were mostly manageable through reintervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally invasive catheter implantation for regional chemotherapy of the liver: a new percutaneous transsubclavian approach. Wacker, FK., Boese-Landgraf, J., Wagner, A., et al.[2019]

A new implantable port design allows for easy insertion of a microcatheter, enabling repeated transarterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC) for advanced liver cancer.

In both in vitro and in vivo studies, the port demonstrated successful catheterization and repeated selective embolization in a pig model, indicating its potential effectiveness for ongoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Repeatable Microcatheter Access Port for Intra-arterial Therapy of Liver Cancer. Fukuoka, Y., Tanaka, T., Nishiofuku, H., et al.[2019]

Citations

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investors.trisaluslifesci.com

investors.trisaluslifesci.com/news-releases/news-release-details/trisalus-life-sciences-announces-real-world-data-demonstrating

Release Details

TriNav patients showed impressive trends toward better outcomes in matched cohort comparisons, including an increased rate of liver transplants.

2.

investors.trisaluslifesci.com

investors.trisaluslifesci.com/news-releases/news-release-details/trisalus-life-sciencesr-announces-publication-pre-clinical-data

Release Details

Results showed the TriNav Infusion System using the PEDD approach markedly outperforms traditional microcatheters in delivering embolic ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05128032

Pressure-enabled Delivery in Radioembolization (TriNav ...

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 ...

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withpower.com

withpower.com/trial/phase-liver-neoplasms-7-2023-0828a

TriNav Infusion System for Liver Cancer · Info for Participants

A totally implanted drug delivery system for hepatic arterial chemotherapy was successfully evaluated in 13 patients, showing reliable ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S1051044324004433

Intra-arterial Pressure-Enabled Drug Delivery Significantly ...

Conclusions. PEDD with a TriNav device significantly improved GM uptake in liver tumors relative to conventional infusion in both lobar and selective procedures ...

6.

investors.trisaluslifesci.com

investors.trisaluslifesci.com/news-releases/news-release-details/trisalus-life-sciences-announces-publication-safety-and-efficacy

Release Details

“This study offers critical insights into how TriNav's Pressure-Enabled Drug Delivery approach may help address therapeutic delivery challenges ...

7.

trinavinfusion.com

trinavinfusion.com/wp-content/uploads/TriNav_Email_PR_TriNavDataINJVIR.pdf

New TriNav Data in JVIR

The TriNav device signi es a potential breakthrough in delivering glass microspheres and other drugs into tumors in a highly controlled and.

8.

synapse.patsnap.com

synapse.patsnap.com/article/trisalus-publishes-data-on-enhanced-tumor-therapy-using-peddE284A2-and-trinavC2AE

TriSalus Publishes Data on Enhanced Tumor Therapy ...

The results indicate that PEDD could be a significant advancement in managing liver cancer by achieving higher concentrations of therapeutics in ...