Pressure-enabled Drug Delivery for Liver Cancer
(PEDIR Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
Disqualifiers: Chemotherapy, Radiotherapy, Hepatic encephalopathy, others
No Placebo Group
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.
12345Eligibility 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.
+30 more
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.
+10 more
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Sequence B: PEDD device for Mapping #1 and standard microcatheter for Mapping #2.Experimental Treatment2 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 Treatment2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Beth Israel Deaconess Medical CenterBoston, MA
Massachusetts General Hospital Cancer CenterBoston, MA
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
TriSalus Life SciencesCollaborator
References
Hepatic arterial infusion chemotherapy with a coaxial reservoir system using a non-braided spiral tip microcatheter. [2021]To evaluate the efficacy and safety of a coaxial reservoir system with a non-braided spiral tip microcatheter and exclusive port for hepatic arterial infusion chemotherapy.
Totally implanted drug delivery system for hepatic arterial chemotherapy. [2013]A totally implanted drug delivery system for hepatic arterial chemotherapy was evaluated in 13 patients with metastatic (11 colon and one carcinoid) or primary (one hepatoma) cancer of the liver. During laparotomy, a Silastic catheter was positioned in the hepatic artery for infusion to the entire liver arterial vasculature as ascertained by low-flow radionuclide angiography with 99Tc-macroaggregated albumin. The catheter was connected to a subcutaneously implanted model 400 Infusaid pump (Metal Bellows Corp, Sharon, MA). Each pump had a 50-ml volume and a set rate (3--6 ml/day) and required refill every 8--16 days. A side port bypassed the pumping mechanism and allowed direct catheter injection for nuclide angiography, for bolus drug administration, or for clearing of a blocked catheter. Pump refills and side port injections were performed by percutaneous injection. The 13 patients in this ongoing study received a median of 6 months (range, 4.5--17) of continuous hepatic arterial infusion. The pump performed reliably with stable (+/- 10%) flow rates and only one malfunction in 2800 cumulative days of use. Flow distribution determined by low-flow radionuclide angiography did not change in 12 patients. Patient acceptance was excellent, with the ability to participate fully in normal daily activities. Eleven patients showed partial hepatic tumor regressions documented by physical examination and nuclide liver scans. All patients were treated with 5-fluorodeoxyuridine. Two patients failed 5-fluorodeoxyuridine therapy and subsequently responded briefly to dichloromethotrexate. This implanted system should facilitate future investigation of regional chemotherapy using these and other agents.
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]Patients with primary and secondary liver cancers generally have a poor prognosis with limited potentially curative options. Liver-directed, intra-arterial therapies such as selective internal radiotherapy (SIRT) and trans-arterial chemoembolization (TACE) are taking a larger role in the management of these patients. The current standard of therapy is for delivery of SIRT or TACE particles through an end-hole microcatheter. Antireflux microcatheters (ARM) are a novel class of microcatheters designed to enhance intra-arterial therapies. These catheters are designed with a flexible tip at the end of the microcatheter, which partially collapses during systole and expands during diastole, reducing antegrade and retrograde particle reflux while allowing for forward flow. Initially designed to reduce the risk of particle reflux during SIRT, there is evidence that ARMs may lead to improved particle distribution to tumors during SIRT. Furthermore, ARMs improve embolization efficiency which may lead to improved disease response from TACE for patients with hepatocellular carcinoma.
Development of Repeatable Microcatheter Access Port for Intra-arterial Therapy of Liver Cancer. [2019]To develop an implantable port in which a microcatheter can be inserted for a combination therapy of repeated transarterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC) for advanced liver cancer.
A dog model using an implanted system for protracted hepatic arterial chemotherapy. [2019]A model for hepatic arterial chemotherapy studies using large dogs and an implantable infusion pump has been developed. Using this technique near complete perfusion (greater than 90%) of the liver can be achieved in vivo as determined by hepatic arterial perfusion scintigraphy with technitium 99m macroaggregated albumin. The system is reliable and has been in use for a total of 1353 days (mean of 104 days, range 52-239) in 13 dogs. Pump implantation causes no apparent acute liver damage based on pre- and post-operative alkaline phosphatase and serum glutamic-pyruvic transaminase determinations and does not affect the general mobility or behavior of the animals. Careful placement of the catheter and attention to the physicochemical properties of the solutions loaded are factors contributing to the success of the model. The model permits comprehensive preclinical pharmacokinetic and toxicologic studies of new or preexistent chemotherapeutic agents in the same device that will be used for later administration in human subjects. By providing the means to examine and develop new treatment modalities, it enables the design of even more potent cytotoxic therapy directed into the tumor vascular bed.