Clinical trial NCT06204159: Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery
Official title: Lipiodol Deposition in Hypervascular Tumors: Endhole vs. Pressure-modulated Delivery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Neuroendocrine Tumors
Keywords: TACE
Catheter
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: TriSalus Life Sciences, Inc.
First posted: 2024-01-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Exploratory
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: volume and density of lipiodol
timeFrame: immediately following TACE
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania, Department of Radiology, Interventional Radiology Division
state: Pennsylvania
Study officials:
References: