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

Abramson Cancer Center at Penn Medicine

Status: Enrolling

Conditions: Neuroendocrine Tumors; Hepatocellular Carcinoma

Treatments: Device: TACE Catheters

Study type: Interventional

Funder types: Other

Identifiers

NCT06204159

853163 (Other Identifier)

UPCC 01223

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

End Hole Catheter followed by TriNav Catheter

Experimental group

Description:

FDA approved catheter Randomization End Hole catheter then TriNav catheter

Treatment:

Device: TACE Catheters

TriNav Catheter followed by End Hole Catheter

Experimental group

Description:

FDA approved catheter Randomization TriNav catheter then End Hold catheter

Treatment:

Device: TACE Catheters