Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery
NCT ID: NCT06204159
Last Updated: 2025-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
12 participants
INTERVENTIONAL
2024-02-01
2026-06-30
Brief Summary
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• 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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End Hole Catheter followed by TriNav Catheter
FDA approved catheter
Randomization End Hole catheter then TriNav catheter
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
TriNav Catheter followed by End Hole Catheter
FDA approved catheter
Randomization TriNav catheter then End Hold catheter
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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TriSalus Life Sciences, Inc.
INDUSTRY
Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Locations
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Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pennsylvania, Department of Radiology, Interventional Radiology Division
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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853163
Identifier Type: OTHER
Identifier Source: secondary_id
UPCC 01223
Identifier Type: -
Identifier Source: org_study_id
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