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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if a special tube can deliver treatment to liver tumors more accurately than usual methods. It targets patients with liver tumors who need precise treatment. The tube helps spread the medicine evenly in the liver.

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 data supports the effectiveness of the TriNav Infusion System treatment for liver cancer?

The research on totally implanted drug delivery systems for liver cancer shows that similar infusion systems can effectively deliver chemotherapy directly to the liver, leading to partial tumor regression in patients. This suggests that the TriNav Infusion System may also be effective in targeting liver tumors by delivering treatment directly to the affected area. ^{1 2 3 4 5}

How is the TriNav Infusion System treatment for liver cancer different from other treatments?

The TriNav Infusion System is unique because it uses a specialized catheter to deliver chemotherapy directly into the liver's blood supply, allowing for targeted treatment of liver cancer. This method can be more effective and have fewer side effects compared to traditional systemic chemotherapy, which affects the whole body. ^{3 5 6 7 8}

Research Team

Armeen Mahvash, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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 over 18 with liver tumors that cannot be surgically removed and can consent to treatment.

Exclusion Criteria

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

My tumor is spreading into surrounding tissues.

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Venous cutdown versus the Seldinger technique for placement of totally implantable venous access ports. [2021]

2. Egypt pubmed.ncbi.nlm.nih.gov

Risk Factors of Catheter-Related Infection in Unplanned Extubation of Totally Implantable Venous-Accessportsin Tumor Patients. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Totally implanted drug delivery system for hepatic arterial chemotherapy. [2013]

4. England 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. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Totally implantable venous access system for cyclic administration of cytotoxic chemotherapy. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Hepatic arterial catheterization combining interventional radiological and laparotomic approaches. [2004]

7. United States pubmed.ncbi.nlm.nih.gov

Development of Repeatable Microcatheter Access Port for Intra-arterial Therapy of Liver Cancer. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Minimally invasive catheter implantation for regional chemotherapy of the liver: a new percutaneous transsubclavian approach. [2019]