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Active, not recruitingNCT06204159TrinavUpdated Jun 11, 2026

Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery

An interventional study of TACE Catheters in Hepatocellular Carcinoma and Neuroendocrine Tumors, sponsored by Abramson Cancer Center at Penn Medicine. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by Abramson Cancer Center at Penn Medicine · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Hepatocellular Carcinoma
  • Neuroendocrine Tumors

Keywords

  • TACE
  • Catheter
03

In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's planned enrollment of 12 is below the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    End Hole Catheter followed by TriNav Catheter

    FDA approved catheter Randomization End Hole catheter then TriNav catheter

    Device: TACE Catheters

  • Experimental
    TriNav Catheter followed by End Hole Catheter

    FDA approved catheter Randomization TriNav catheter then End Hold catheter

    Device: TACE Catheters

Interventions

  • DeviceTACE 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

06

What researchers measure

Primary outcomes

  1. volume and density of lipiodol

    To estimate the relative volume and density of lipiodol deposition in hypervascular liver tumors

    Time frame: immediately following TACE

07

Study locations

2 sites
  • Abramson Cancer Center of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • University of Pennsylvania, Department of Radiology, Interventional Radiology Division
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06204159
Lead sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
TriSalus Life Sciences, Inc.
Responsible party
Sponsor
First posted
Jan 12, 2024
Start date
Feb 1, 2024
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 11, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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