Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery

Hepatocellular Carcinoma Clinical Trial

— Trinav  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06204159
• Other study ID #: UPCC 01223
• Secondary ID: 853163
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Abashai Woodard
• Phone: 215-746-07050
• Email: abashai.woodard[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 30, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatocellular Carcinoma
• Neuroendocrine Tumors

Intervention

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

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pennsylvania, Department of Radiology, Interventional Radiology Division	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	TriSalus Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	volume and density of lipiodol	To estimate the relative volume and density of lipiodol deposition in hypervascular liver tumors	immediately following TACE