Pressure-enabled Drug Delivery for Liver Cancer

(PEDIR Trial)

Recruiting at 1 trial location

Overseen By Patrick D Sutphin, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Chemotherapy, Radiotherapy, Hepatic encephalopathy, others

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

Compensation: Varies

Number of Visits: 3

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy or radiotherapy within 4 to 6 weeks before joining the study.

How is the Pressure-enabled Drug Delivery (PEDD) treatment for liver cancer different from other treatments?

The PEDD treatment for liver cancer is unique because it uses a specialized microcatheter system to deliver drugs directly to the liver with enhanced precision, potentially improving drug distribution and reducing side effects compared to standard methods. ^{1 2 3 4 5}

Research Team

Patrick D Sutphin, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Adults with liver cancer or colorectal metastases to the liver, who can't have surgery or thermal ablation. They should be in relatively good health (ECOG <2), with a life expectancy over 16 weeks and adequate organ function. Participants must not be pregnant, nursing, or planning to conceive soon. Those with stable extrahepatic disease may qualify.

Inclusion Criteria

Hemoglobin: ≥ 8.5 g/dL

My organs and bone marrow are working well.

I can do most of my daily activities by myself.

Exclusion Criteria

I have had radiation or specific artery treatments to my liver before.

More than half of my liver is affected by cancer.

I have received treatment for a condition affecting the Ampulla of Vater.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Mapping Procedure

Participants undergo a mapping procedure to evaluate blood supply to the liver and tumor using angiography and radiotracer injection

2-21 days before treatment

1 visit (in-person)

Radioembolization Treatment

Participants receive radioembolization treatment with an additional mapping procedure on the treatment day

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Multiple visits (in-person)

Treatment Details

Interventions

• PEDD device
• Standard microcatheter

Trial Overview The study is testing whether using a Pressure Enabled Drug Delivery (PEDD) device during mapping for radioembolization improves treatment delivery to liver tumors compared to a standard microcatheter.

Participant Groups

Group I: Sequence B: PEDD device for Mapping #1 and standard microcatheter for Mapping #2. Experimental Treatment 2 Interventions

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.

Group II: Sequence A: Standard microcatheter for Mapping #1 and PEDD device for Mapping #2. Experimental Treatment 2 Interventions

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.

PEDD device is already approved in United States for the following indications:

Approved in United States as TriNav Infusion System for:

• Liver cancer

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

TriSalus Life Sciences, Inc.

Industry Sponsor

Trials

10

Recruited

420+

TriSalus Life Sciences

Collaborator

Trials

5

Recruited

70+

Findings from Research

The coaxial reservoir system with a non-braided microcatheter was successfully implanted in 100% of the 80 patients, demonstrating its efficacy for hepatic arterial infusion chemotherapy.

While the system is generally safe, there were some complications, including a 10% rate of hepatic arterial occlusion, indicating that while effective, careful monitoring is necessary during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatic arterial infusion chemotherapy with a coaxial reservoir system using a non-braided spiral tip microcatheter. Koganemaru, M., Abe, T., Iwamoto, R., et al.[2021]

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]

Antireflux microcatheters (ARMs) are a new type of microcatheter that can enhance liver-directed therapies like selective internal radiotherapy (SIRT) and trans-arterial chemoembolization (TACE) by reducing particle reflux and improving drug delivery to tumors.

Using ARMs may lead to better particle distribution and embolization efficiency, potentially resulting in improved disease response for patients with liver cancers, particularly hepatocellular carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Surefire's precision direct-to-tumor embolization device to augment therapeutic response to intra-arterial, liver-directed therapies for patients with primary and secondary liver cancers. Kim, AY., Miller, A.[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]

A new model for hepatic arterial chemotherapy using large dogs and an implantable infusion pump allows for over 90% perfusion of the liver, making it a reliable method for studying liver-targeted treatments.

The implantation of the pump does not cause acute liver damage or affect the dogs' mobility, indicating its safety for use in preclinical studies of chemotherapeutic agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A dog model using an implanted system for protracted hepatic arterial chemotherapy. Wollner, IS., Knutsen, CA., Ullrich, KA., et al.[2019]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Hepatic arterial infusion chemotherapy with a coaxial reservoir system using a non-braided spiral tip microcatheter. [2021]

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

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

3. England pubmed.ncbi.nlm.nih.gov

Evaluation of Surefire's precision direct-to-tumor embolization device to augment therapeutic response to intra-arterial, liver-directed therapies for patients with primary and secondary liver cancers. [2019]

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

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

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

A dog model using an implanted system for protracted hepatic arterial chemotherapy. [2019]