Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery (NCT06204159) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery
United States12 participantsStarted 2024-02-01
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 previou…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.