Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery

NCT06204159 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: UPCC 01223853163
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hepatocellular Carcinoma; Neuroendocrine Tumors

Keywords

TACE; Catheter

Outcome Measures

Primary Outcomes (1)

• volume and density of lipiodol

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

  immediately following TACE

Study Arms (2)

End Hole Catheter followed by TriNav Catheter

EXPERIMENTAL

FDA approved catheter Randomization End Hole catheter then TriNav catheter

Device: TACE Catheters

TriNav Catheter followed by End Hole Catheter

EXPERIMENTAL

FDA approved catheter Randomization TriNav catheter then End Hold catheter

Device: TACE Catheters

Interventions

TACE Catheters DEVICE

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

End Hole Catheter followed by TriNav Catheter; TriNav Catheter followed by End Hole Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• TriSalus Life Sciences, Inc.: collaborator

Study Sites (2)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania, Department of Radiology, Interventional Radiology Division

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Exploratory

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 12, 2024
• Study Start: February 1, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

US (2)