Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06204159
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Abramson Cancer Center at Penn Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Hepatocellular Carcinoma, Neuroendocrine Tumors

Additional Details

Hepatocellular (HCC) and neuroendocrine (NET) liver metastases undergoing Lipiodol transarterial chemoembolization (TACE) will be randomized to endhole vs.#46; pressure-modulated catheter delivery. Lipiodol deposition will be quantified and correlated with volumetric necrosis, response, and local progression.

Arms & Interventions

Arms

Experimental: End Hole Catheter followed by TriNav Catheter

FDA approved catheter Randomization End Hole catheter then TriNav catheter

Experimental: TriNav Catheter followed by End Hole Catheter

FDA approved catheter Randomization TriNav catheter then End Hold catheter

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Philadelphia, Pennsylvania

Status

Recruiting

Address

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Gregory Nadolski, MD

[email protected]

855-216-0098

Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

University of Pennsylvania, Department of Radiology, Interventional Radiology Division

Philadelphia, Pennsylvania, 19104

Site Contact

Abashai Woodard

[email protected]

215-746-7050

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