Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery (Trinav)

June 9, 2026 updated by: Abramson Cancer Center at Penn Medicine

Lipiodol Deposition in Hypervascular Tumors: Endhole vs. Pressure-modulated Delivery

The goal of this clinical trial is to compare CT scan of the coverage of tumors treated with TACE using End Hole catheters to those treated with the TriNav catheter that alters tissue pressure. Both catheters are FDA approved for delivery of TACE.

• Is there a difference in CT appearance with delivery in the type of catheter used during the TACE procedure?

Participants will be asked to undergo a TACE procedure, a CT scan and review of their medical record to compare End Hole and TriNav catheters during TACE procedures.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Hepatocellular (HCC) and neuroendocrine (NET) liver metastases undergoing Lipiodol transarterial chemoembolization (TACE) will be randomized to endhole vs. pressure-modulated catheter delivery. Lipiodol deposition will be quantified and correlated with volumetric necrosis, response, and local progression.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania, Department of Radiology, Interventional Radiology Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female, aged >18 years.
  • Plan to undergo lipiodol TACE for HCC or NET liver metastases
  • Bilobar disease or distribution for which staged therapy (more than one TACE) for distinct target tumors is planned
  • Liver tumor burden does not exceed 50% of the liver volume
  • Patent main portal vein
  • Life expectancy of greater than 6 months
  • ECOG performance status 0-2
  • Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl
  • Adequate marrow and renal function as defined as:
  • Platelets >75,000/mcL (may be corrected by transfusion)
  • Serum creatinine < 2.0 mg/dl
  • For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such contraception from beginning of study treatment until 1 month following last TACE treatment, as recommended for TACE treatments not conducted within the trial.
  • For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner from first study treatment until 1 month following last TACE treatment.
  • Provision of signed and dated informed consent form and ability to consent for oneself.
  • Stated willingness to comply with all study procedures and availability for the study duration.

Exclusion Criteria:

  • Absolute contraindication to contrast-enhanced MRI
  • Absolute contraindication to intravenous iodinated contrast, including history of previous severe contrast reaction or moderate reaction not mitigated by appropriate pre-medication
  • Pregnancy or lactation
  • Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: End Hole Catheter followed by TriNav Catheter

FDA approved catheter

Randomization End Hole catheter then TriNav catheter
Device: TACE Catheters

End Hole and TriNav catheters are FDA approved. This study is comparing the two for chemotherapy delivery during the TACE procedure.

This study will randomize which catheter is used for the first TACE procedure and the other catheter will be used for the second TACE procedure
Experimental: TriNav Catheter followed by End Hole Catheter

FDA approved catheter

Randomization TriNav catheter then End Hold catheter
Device: TACE Catheters

End Hole and TriNav catheters are FDA approved. This study is comparing the two for chemotherapy delivery during the TACE procedure.

This study will randomize which catheter is used for the first TACE procedure and the other catheter will be used for the second TACE procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
volume and density of lipiodol
Time Frame: immediately following TACE
To estimate the relative volume and density of lipiodol deposition in hypervascular liver tumors
immediately following TACE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Collaborators

TriSalus Life Sciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 3, 2024

First Submitted That Met QC Criteria

January 3, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 01223
  • 853163 (Other Identifier: University of Pennsylvania IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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