NCT06204159Active, not recruiting
Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery
Lipiodol Deposition in Hypervascular Tumors: Endhole vs. Pressure-modulated Delivery
Source: ClinicalTrials.gov · Last updated 11 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 3 Jan 2024
- Start date
- Feb 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- NCT number
- NCT06204159
What you commit to
- Study type: Interventional
- Planned participants: 12
- From Feb 2024 to the primary completion date, Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Absolute contraindication to intravenous iodinated contrast, including history of previous severe contrast reaction or moderate reaction not mitigated by appropriate pre-medication
Other illness
- 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
Other
- Absolute contraindication to contrast-enhanced MRI
- Pregnancy or lactation
- Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pennsylvania, Department of Radiology, Interventional Radiology Division Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.