Status:
ACTIVE_NOT_RECRUITING
Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
TriSalus Life Sciences, Inc.
Conditions:
Hepatocellular Carcinoma
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
NA
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 c...
Detailed Description
Hepatocellular (HCC) and neuroendocrine (NET) liver metastases undergoing Lipiodol transarterial chemoembolization (TACE) will be randomized to endhole vs. pressure-modulated catheter delivery. Lipiod...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06204159
Start Date
February 1 2024
End Date
June 30 2026
Last Update
May 20 2025
Active Locations (2)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
2
University of Pennsylvania, Department of Radiology, Interventional Radiology Division
Philadelphia, Pennsylvania, United States, 19104