Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-31 @ 2:16 AM
Study NCT ID:
NCT05128032
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2021-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pressure-enabled Delivery in Radioembolization (TriNav Study)
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEDIR
Brief Summary:
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
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
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: